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Mivado GlobalPerformance harnesses AI and digital innovation to transform Biopharma and healthcare, empowering organizations to deliver smarter, more connected, and more personalized pharma and health experiences while improving enterprise performance. We’re looking for an AI and Digital Transformation Specialist who is a professional driving organizational change by integrating AI and digital solutions into business processes, optimizing operations, and ensuring measurable impact.

A strategist and builder who can move between boardroom and sprint room. You'll lead AI-powered transformation programs,  modernizing processes, enabling data-driven decisions, and embedding intelligent automation into the fabric of how organizations operate and grow.[/vc_column_text][vc_column_text css=""]

Transformation pillars

• - AI Strategy & Roadmapping: Define where and how AI creates durable business value, from use-case prioritization to building and buying decisions.
• - Process re-engineering: Map existing workflows, identify automation opportunities, and redesign end-to-end processes around AI capabilities.
• - Data & platform enablement: Assess data infrastructure readiness; close gaps in data quality, integration, and governance to unlock ML pipelines.
• - Change management: Drive organizational adoption by ensuring training programs, stakeholder alignment, and culture shifts toward AI-first ways of working.
• - Responsible AI & ethics: Embed fairness, transparency, and accountability checkpoints into every transformation initiative from day one.
• - Outcome measurement: Define KPIs, build dashboards, and run post-implementation reviews to demonstrate ROI and course-correct fast.

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Key responsibilities

1. Lead discovery engagements and facilitate executive workshops, interview process owners, and synthesize findings into transformation opportunity maps with estimated value and complexity. 2. Design AI-powered solutions with architect intelligent automation, generative AI, and ML-driven decision systems aligned to business objectives and technology constraints. 3. Build and execute roadmaps to translate strategy into phased delivery plans with clear milestones, resource requirements, and dependency maps across business and technology teams. 4. Own stakeholder communication to prepare C-suite briefings, steering committee updates, and board-level narratives that connect AI investments to strategic outcomes. 5. Evaluate and integrate AI tooling by assessing vendor solutions (LLM platforms, RPA, analytics tools) against client needs and orchestrate integrations with existing enterprise systems. 6. Drive digital upskilling by designing capability-building programs that help business units understand, trust, and leverage AI tools in their daily work. 7. Manage transformation risk and identify technical debt, data quality gaps, regulatory exposure, and change fatigue early, with mitigation plans ready before they become blockers.

Skills & experience

• - 5+ years in digital transformation, management consulting, or enterprise technology. Proven track record delivering cross-functional programs at scale.
• - Hands-on exposure to LLMs, ML workflows, and agentic systems. Comfortable evaluating foundation models and automation platforms (UiPath, Power Automate, Vertex, Azure AI).
• - SQL, data modeling basics, and BI tools (Power BI, Tableau, Looker). Able to assess data readiness and collaborate with data engineering teams.
• - Agile / SAFe delivery, design thinking facilitation, business case development, and benefits realization management.
• - Financial services, retail, healthcare, or public sector preferred. Regulated industry experience is a strong plus.
• - PMP, SAFe, TOGAF, or AWS/Azure/GCP AI certifications are valued. An MBA or equivalent postgraduate education is beneficial.

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[vc_row][vc_column][vc_column_text css=""]Mivado GlobalPerformance is seeking a GxP Compliance Advisor who will act as the organization’s authority on GMP, GAMP, QA/QC workflows, and regulatory compliance. This role ensures that every solution designed and implemented using a low-code platform aligns with real-world pharma operations and global regulatory expectations. The incumbent will act as the credibility anchor during sales cycles, the process architect during implementation, and the compliance guardian throughout the customer lifecycle.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text css=""]

Key Responsibilities

1. Regulatory & Compliance Leadership

• - Interpret and apply global regulatory frameworks: GMP, GAMP 5, 21 CFR Part 11, Annex 11, WHO, MHRA, PIC/S.
• - Ensure that all solution designs adhere to data integrity principles (ALCOA+).
• - Advise clients on audit readiness and best practices for compliance.
• - Review validation deliverables (URS, FRS, Risk Assessments, IQ/OQ/PQ).

2. Process Mapping & Digital Transformation

• - Analyze existing pharma workflows (QA, QC, Manufacturing, R&D, Engineering).
• - Translate manual or legacy processes into optimized digital workflows.
• - Define functional requirements for modules such as:
  • • -- eQMS (CAPA, Deviations, Change Control, Complaints)
    • --LIMS (sample management, stability, COA)
    • --MES/eBR (batch records, equipment logs)
    • --DMS (SOPs, controlled documents)
    • --EMS/eLogbook (equipment management)
• - Identify process gaps and recommend improvements aligned with industry standards.

3. Client Engagement & Advisory

• - Lead discovery workshops with QA Heads, QC Managers, Plant Managers, and IT teams.
• - Provide domain expertise during pre?sales demos and solution presentations.
• - Act as a trusted advisor throughout the customer journey.
• - Support Business Development with domain?specific insights and proposal content.

4. Implementation Support

• - Collaborate with implementation teams to ensure functional accuracy.
• - Validate workflow configurations, forms, dashboards, and reports.
• - Ensure system configurations align with regulatory expectations.
• - Participate in UAT planning, execution, and documentation.

5. Documentation & Validation

• - Review and approve:
  • • --URS/FRS
    • --Process maps
    • --Validation protocols (IQ/OQ/PQ)
    • --SOPs and training materials
• - Ensure documentation meets GxP and audit standards.

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Required Skills & Qualifications

Education

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field.

Industry Experience

• _  3+ years in pharma/biotech operations, QA, QC, manufacturing, or regulatory affairs.
• _ Experience with QMS, LIMS, MES, DMS, or other GxP systems is a strong asset.
• _ Hands?on involvement in audits, CAPA, deviations, change control, batch release, or lab operations.
• _ Deep understanding of GxP processes and digitalization trends.
• _ Ability to map business processes to software capabilities.
• _ Familiarity with CSV (Computer System Validation) principles.
• _ Strong analytical and documentation skills.

Soft Skills

• _ Excellent communication and presentation abilities.
• _ Strong stakeholder management and influence.
• _ Ability to simplify complex regulatory concepts.
• _ Close attention to detail and structured thinking.

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[vc_row][vc_column][vc_column_text css=""]The Data Migration Specialist is responsible for planning, executing, and validating the migration of critical pharma data, including lab results, quality records, SOPs, batch logs, equipment data, and historical documents. This role ensures accuracy, integrity, compliance, and traceability throughout the migration process, enabling clients to transition smoothly from paper-based or legacy systems to modern digital solutions.

Key Responsibilities

• _ Conduct detailed assessments of existing data sources (paper, Excel, legacy LIMS/QMS/MES systems).
• _ Identify data structures, formats, gaps, inconsistencies, and quality issues.
• _ Develop data migration strategies, mapping documents, and timelines.
• _ Collaborate with domain experts to understand regulatory and operational requirements.
• _ Extract data from multiple sources, including scanned documents, spreadsheets, databases, and legacy applications.
• _ Clean, normalize, and transform data to meet Customer requirements.
• _ Build and execute data import templates, scripts, or low-code workflows.
• _ Ensure data integrity, completeness, and traceability throughout the migration process.
• _ Perform data validation checks before, during, and after migration.
• _ Work with QA teams to ensure compliance with GxP, CSV, and audit requirements.
• _ Document validation results and support IQ/OQ/PQ activities related to data migration.
• _ Work closely with implementation specialists, domain experts, and customer success teams.
• _ Participate in client workshops to clarify data requirements and expectations.
• _ Provide technical guidance to clients on preparing and cleaning their data.
• _ Maintain detailed documentation of data mapping, transformation rules, and migration procedures.
• _ Prepare migration reports, audit trails, and compliance documentation.
• _ Track issues, risks, and resolutions throughout the migration lifecycle.
• _ Train client teams on best practices for data preparation.
• _ Provide post-migration support to ensure data accuracy and user confidence.

Required Skills & Qualifications

• _ Bachelor’s degree in Computer Science, Data Science, Life Sciences, Engineering, or related field.
• _ 3+ Years of experience in the same or related field.
• _ Strong experience with ETL (Extract, Transform, Load) processes, data modeling, and data cleansing.
• _ Proficiency in Excel, SQL, or data transformation tools.
• _ Familiarity with low-code/no-code platforms.
• _ Understanding of structured and unstructured data formats (CSV, XML, PDF, etc.).
• _ Experience in pharma, biotech, or regulated industries is highly preferred.
• _ Understanding of GxP, GMP, GAMP 5, and data integrity principles (ALCOA+).

Soft Skills

• _ Strong attention to detail and analytical thinking.
• _ Excellent communication and documentation abilities.
• _ Ability to manage multiple projects and deadlines.
• _ Collaborative mindset with a customer-centric approach.

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[vc_row][vc_column][vc_column_text css=""]Le conseiller en prévention – Gestion des matières dangereuses offre des services-conseils spécialisés en SIMDUT 2015 auprès d'une clientèle variée d'entreprises québécoises. Il accompagne les organisations dans la mise en conformité de leurs obligations légales, la gestion de leurs produits chimiques dangereux et le développement d'une culture de prévention durable.

Responsabilités principales

• Analyser les obligations des clients en vertu du Règlement sur l'information concernant les produits dangereux (RIDP) et de la Loi sur la santé et la sécurité du travail (LSST)
• Réaliser des audits SIMDUT et produire des rapports d'écarts avec plans d'action
• Assurer une veille réglementaire continue (CNESST, Santé Canada, SIMDUT 2015 / SGH)
• Réviser, valider et classer les FDS des clients selon les normes en vigueur
• Conseiller sur la mise à jour et l'accessibilité des FDS en milieu de travail
• Concevoir et animer des formations SIMDUT adaptées aux différents secteurs d'activité
• Développer du matériel pédagogique (guides, procédures, outils visuels)
• Agir à titre de personne-ressource auprès des comités de santé et sécurité (CSST/CNESST)
• Soutenir les clients lors d'inspections ou d'enquêtes de la CNESST
• Participer à l'élaboration de programmes de prévention incluant le volet matières dangereuses

Compétences requises

• Connaissance approfondie du SIMDUT 2015 et du Système général harmonisé (SGH)
• Maîtrise de la réglementation québécoise en SST (LSST, RIDP, LPDSGD)
• Capacité à vulgariser l'information technique pour des publics non spécialisés
• Excellentes aptitudes en communication écrite et orale en français
• Sens de l'organisation, autonomie et gestion de multiples mandats simultanés

Titres professionnels (atouts majeurs) 

• Professionnel en hygiène industrielle agréé (ROH ou CIH), ou
• Membre de l'Ordre des conseillers en ressources humaines agréés (CRHA/CRIA) avec spécialisation en SST,

Formation et expérience

• Baccalauréat en chimie, en santé et sécurité du travail, en sciences de l'environnement ou dans un domaine connexe (ou expérience équivalente reconnue)
• Minimum de 3 à 5 ans d'expérience en SST, idéalement en contexte industriel ou manufacturier
• Certification en SIMDUT ou titre de conseiller en prévention (un atout majeur)
• Membre de l'Ordre des chimistes (OCQ)
• Sens du service client et capacité à établir des relations de confiance.
• Pédagogie et capacité à expliquer des concepts techniques.
• Adaptabilité et proactivité.

Conditions particulières

• Déplacements réguliers chez les clients à travers le Québec
• Permis de conduire valide requis
• Bilinguisme fonctionnel (français/anglais) — un atout pour servir des clients pancanadiens

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The Customer Success Manager ensures that clients achieve maximum value from AmpleLogic’s digital solutions after implementation. This role focuses on adoption, satisfaction, renewals, and expansion opportunities. The CSM acts as the long-term partner for clients, guiding them through best practices, continuous improvement, and additional module adoption.

This is a relationship-driven, strategic role essential for building a profitable and sustainable reseller business.

 Key Responsibilities

• - Serve as the primary point of contact for assigned clients after go-live.
• - Build strong, trusted relationships with QA, QC, IT, Manufacturing, and leadership teams.
• - Ensure customers fully adopt and utilize implemented modules (eQMS, LIMS, MES, DMS, EMS, etc.).
• - Monitor usage metrics and proactively address adoption gaps.
• - Provide guidance on best practices for digital workflows and compliance.
• - Conduct regular check-ins, business reviews, and performance assessments.
• - Coordinate with technical support and implementation teams to resolve issues.
• - Track and manage customer tickets, ensuring timely and high-quality responses.
• - Escalate critical issues and follow through until resolution.
• - Drive contract renewals by demonstrating value and ROI.
• - Identify upsell opportunities (eLogbook, LMS, EMS, additional QMS modules, etc.).
• - Prepare business cases and collaborate with sales for expansion proposals.
• - Conduct refresher training sessions for end-users and new employees.
• - Provide documentation, guides, and resources to support ongoing usage.
• - Gather customer feedback and translate it into actionable insights.
• - Work with product and implementation teams to improve solutions.
• - Track customer satisfaction and implement improvement plans.

 Required Skills & Qualifications

• - Bachelor’s degree in Life Sciences, Engineering, Business, or related field.
• - Experience in pharma, biotech, medical devices, or regulated industries is a strong asset.
• - Familiarity with QMS, LIMS, MES, DMS, or other GxP systems is preferred.
• - Understanding of digital workflows, compliance requirements, and GxP concepts.
• - Ability to interpret usage data and identify improvement opportunities.
• - Comfortable with low-code/no-code platforms (experience with AmpleLogic is a plus).

 Soft Skills

• - Excellent communication and relationship-building abilities.
• - Strong problem-solving and analytical thinking.
• - Ability to manage multiple clients and priorities.
• - High emotional intelligence and customer-centric mindset.
• - An ideal candidate is a relationship-driven professional who enjoys helping clients succeed, Someone who understands both technology and regulated industry workflows, a proactive communicator who anticipates needs before they become problems, and is passionate about digital transformation in life sciences.

Additional Information

 We are an equal opportunity employer.

 

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[vc_row][vc_column][vc_column_text css=""]Regulatory & Quality Compliance Consultant is a domain Expert providing the deep regulatory, operational, and compliance expertise needed to guide customers through digital transformation initiatives using Low-Cod Application solutions (LIMS, eQMS, MES, DMS, EMS). This role ensures that proposed solutions align with GMP, GAMP, and global regulatory expectations while helping clients optimize their quality and manufacturing processes. They act as the credibility anchor in sales cycles and the compliance authority during implementation.

Key Responsibilities

•  Interpret and explain regulatory requirements (GMP, GAMP 5, 21 CFR Part 11, Annex 11, WHO, MHRA, PIC/S).
• _ Advise clients on best practices for digitalizing quality and manufacturing processes.
• _ Ensure solution designs meet compliance expectations for audits and inspections.
• _ Guide validation deliverables (URS, FRS, IQ/OQ/PQ).
• _ Translate pharma workflows into digital workflows using AmpleLogic modules (eQMS, LIMS, MES, DMS, EMS, eLogbook, etc.).
• _ Identify process gaps and recommend improvements aligned with industry standards.
• _ Collaborate with pre-sales and implementation teams to ensure functional accuracy.
• _ Lead workshops with QA, QC, Manufacturing, and Regulatory teams.
• _ Support pre-sales discussions by providing domain credibility and process insights.
• _ Act as a trusted advisor to senior stakeholders (QA Heads, Plant Managers, IT Directors).
• _ Review and contribute to URS, SOPs, validation documents, and risk assessments.
• _ Ensure documentation aligns with regulatory expectations and internal quality standards.
• _ Conduct internal training for sales, pre-sales, and implementation teams.
• _ Deliver client training on GxP processes, compliance, and system usage.

Required Skills & Qualifications

• _ Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field.
• _ 5+ years in pharma/biotech operations, QA, QC, manufacturing, or regulatory affairs.
• _ Hands-on experience with QMS, LIMS, MES, or other GxP systems is highly preferred.
• _ Familiarity with audits, CAPA, deviations, change control, batch records, and lab workflows.
• _ Strong understanding of GxP processes and digitalization trends.
• _ Ability to map business processes to software capabilities.
• _ Knowledge of CSV (Computer System Validation) principles.

Soft Skills

• _ Excellent communication and presentation abilities.
• _ Strong analytical and problem-solving mindset.
• _ Ability to influence stakeholders and build trust quickly.
• _ Comfortable working in cross-functional teams.

Ideal Candidate Profile is A seasoned pharma professional who understands both operations and compliance, Someone who can confidently speak with auditors, QA heads, and plant leadership, A natural educator who enjoys simplifying complex regulatory concepts, and Passionate about digital transformation in life sciences.

Additional Information

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Mivado GlobalPerformance is seeking a bilingual Technical Sales Consultant. Your primary role is to promote, demonstrate, and sell complex technical goods or services (e.g., software, industrial equipment) to business clients by bridging the gap between customer needs and low-code digital solutions. You combine technical expertise, pharma domain understanding, and strong communication skills to deliver compelling demos, solution designs, and technical guidance throughout the sales cycle.

You understand both the software (LIMS, eQMS, MES, DMS) and pharma workflows. You translate customer pain points into product demonstrations that resonate. Critical for closing deals in regulated industries.

Key Responsibilities

• Conduct discovery sessions to understand customer pain points, workflows, and compliance requirements (GMP, GAMP, FDA, WHO, EU Annex 11).
• Deliver tailored product demonstrations for Biopharma Solutions (LIMS, eQMS, MES, DMS, EMS, eLogbook, LMS, etc.).
• Prepare solution proposals, functional specifications, and technical documentation.
• Support RFP/RFI responses with accurate technical and functional details.
• Map customer requirements to our low-code platform capabilities.
• Design high-level solution architectures, workflows, and module configurations.
• Recommend best-practice digitalization approaches for pharma and biotech clients.
• Collaborate with implementation teams to ensure smooth handover after deal closure.
• Work closely with Business Development Managers to strategize on opportunities.
• Participate in client meetings, workshops, and technical discussions.
• Provide technical justification that supports pricing, scope, and timelines.
• Conduct product training sessions for prospects and internal teams.
• Stay updated on AmpleLogic product updates, new modules, and industry trends.
• Understand integrations (ERP, LIMS, QMS, MES, SCADA, IoT devices).

Education

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field.
• Bilingual: French and English

 Technical Skills

• Must have at least 0-2 yrs of cGMP experience and technical expertise in Low-Code Application
• Strong understanding of enterprise software (LIMS, QMS, MES, DMS, EMS).
• Ability to design workflows, forms, dashboards, and data models.
• Familiarity with low-code/no-code code platforms (experience with AmpleLogic is a plus).
• Understanding of CSV (Computer System Validation) concepts.
• Knowledge of pharma manufacturing, quality systems, lab operations, or regulatory compliance.
• Experience with GMP, GAMP 5, 21 CFR Part 11, Annex 11 is highly desirable.

Soft Skills

• Excellent communication and presentation skills.
• Comfortable interacting with CXOs, QA heads, IT managers, and plant teams.

An ideal candidate is a hybrid professional who understands both technology and pharmaceutical operations. Someone who enjoys presenting, problem-solving, and designing solutions, a proactive communicator who can simplify complex concepts, and is comfortable working in a fast-paced, high-pressure environment in a growth digital transformation environment.

Additional Information

We are an equal opportunity employer.

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Mivado GlobalPerformance est à la recherche d'un(e) consultant(e) qualité et conformité réglementaire qui sera basé(e) à Lomé, au Togo.

Le profil recherché est celui d'un expert en assurance qualité, chargé d'accompagner nos clients des secteurs pharmaceutique, médical et agroalimentaire dans la mise en place et le maintien de systèmes de management de la qualité robustes. Il/Elle intervient en tant que conseiller stratégique afin de garantir la conformité réglementaire de ses activités, tout en optimisant ses processus et en réduisant les risques.

Responsabilités principales

 Expertise réglementaire:

• Maîtriser les réglementations spécifiques aux secteurs pharmaceutique, médical et agroalimentaire (BPF, BPL, normes ISO, etc.).
• Soutenir nos clients lors des demandes d’homologation et d’autorisation de mise en marché de leurs produits.
• Effectuer une veille réglementaire continue pour informer les clients des évolutions législatives.

Audit et évaluation:

• Réaliser des audits de systèmes qualité, de processus et de produits/services.
• Évaluer la conformité aux normes et réglementations en vigueur.
• Identifier les écarts et les opportunités d'amélioration.

Conseil stratégique:

• Accompagner les clients dans la définition et la mise en œuvre de leur stratégie qualité.
• Proposer des solutions personnalisées pour répondre aux enjeux spécifiques de chaque client.
• Assister les clients dans la préparation aux audits réglementaires.

Formation et accompagnement:

• Former les équipes des clients aux bonnes pratiques de qualité et aux exigences réglementaires.
• Accompagner les clients dans la mise en place d'actions correctives et préventives.

Documentation:

• Élaborer des procédures, des modes opératoires et des documents qualité.
• Rédiger des rapports d'audit et des plans d'amélioration.

Profil recherché

 Formation:

• Formation de niveau minimum Bac +5 idéalement
• Diplôme universitaire en sciences de la vie, ingénierie, qualité ou équivalent.

Expérience:

• Expérience significative dans le domaine de la qualité et de la conformité réglementaire dans au moins un des secteurs visés (pharmaceutique, médical, agroalimentaire).
• Minimum de 0 à 3 années d'expérience dans un rôle similaire.
• Connaissance approfondie des normes et réglementations applicables (BPF, ISO 9001; ISO 13485; HACCP; FSSC 22000; etc.)

Compétences:

• Capacités d'analyse et de synthèse.
• Excellentes qualités de communication écrite et orale.
• Sens de l'organisation et rigueur.
• Aptitude à travailler en équipe et en autonomie.

Qualités personnelles:

• Sens du service client et capacité à établir des relations de confiance.
• Pédagogie et capacité à expliquer des concepts techniques.
• Adaptabilité et proactivité.

Atouts supplémentaires

• Expérience en audit: certification d'auditeur interne (BPF; ISO 9001; ISO 13485; HACCP; FSSC 22000).
• Connaissance de plusieurs langues: anglais courant obligatoire, toute autre langue (allemand, espagnol, mandarin) serait un plus.
• Expérience en gestion de projets.

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Mivado GlobalPerformance is seeking a Biopharma Process Engineer to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

You will participate in design and process engineering activities for medium and large-scale projects. You will provide technical solutions in compliance with the applicable standards in force and will have the following responsibilities in particular:

• Participate in project definition;
• Analyze the client's needs to determine the optimal process to use.
• Perform mass and energy balances.
• Design and specify equipment (Single Use) and process installations (pumps, heat exchangers, control valves, piping, and instrumentation, etc.).
• Calculate process utility requirements (steam, chilled water, compressed air, etc.).
• Prepare and execute technical plans and specifications.
• Review and approve technical deliverables and the design of PFD and P&ID process diagrams.
• Participate in risk analyses (HAZOP or others).
• Establish project budgets and schedules.
• Coordinate the installation, start-up, validation, and maintenance of process equipment.
• Collaborate with the interdisciplinary project team.
• Follow up with suppliers, contractors, and customers.

Skills and Experience

• An engineering degree in chemical or biotechnology engineering or other relevant specialty.
• 2 to 5 years of experience, preferably in the chemical or industrial industry.
• Knowledge of norms and standards (ISPE Guides; ASME-BPE).
• Experience in consulting engineering (asset).
• Factory experience.
• Knowledge of CAD software such as AutoCAD.
• Experience with process simulation software such as Superpro Designer, Aspen Hysys, Pipe-Flo, HTRI, etc

Required Skills

• Excellent communication and leadership skills;
• Openness & positive attitude;
• Proactivity and autonomy;
• Striving for excellence;
• Sense of organization and rigor;
• Technical know-how;

Additional Information

We are an equal opportunity employer.

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Mivado GlobalPerformance is seeking a Specialist in process/chemical engineering to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any type of bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

• Works safely by EHS guidelines and adheres to Client cGMP Quality Management System requirements.
• Becomes subject matter expert (SME), remains trained and qualified in the area of expertise, and displays initiative in personal development opportunities further to enhance skills and expertise relevant to the position.
• Provide SME troubleshooting/oversight and support execution of the batch as needed to deliver the site key performance indicators of Right First Time and On Time Delivery.
• Builds partnerships and works collaboratively with the Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors as per company core values.
• Support operational production and facility maintenance planning as well as the transfer of new technologies/procedures/equipment to Operations to address production demands as per S&OP.
• Review manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
• Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
• Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing storyboards and providing SME input during audit.
• Drive continuous improvement in Operations.

Skills and Experience

• Must have at least 2+ yrs' cGMP experience and technical expertise in Upstream and/or Downstream Processing.
• Have excellent written & verbal communication skills.
• Ability to work unsupervised, under pressure on multiple tasks and manage priorities independently.
• Possess strong organizational and planning skills and a commitment to excellence.
• Preferred to be educated to minimum Degree level in Biology, Chemistry or related field.
• Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.
• Use of DeltaV, Dynamic 365, MasterControl, eDMS, Trackwise, SAP.

Additional Information

We are an equal opportunity employer.

Mivado GlobalPerformance is looking for a Specialist in process/chemical engineering to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any type of bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

• Provide technical guidance into the design, project management, commissioning, and start-up of equipment and facilities, for upgrades, renovations, and expansions of client facilities and processes.
• Support project execution from Feasibility through to project completion/handover, including all project stages such as:
  • Feasibility
  • Concept Design, Basic Design, Detailed Design
  • Procurement
  • Construction
  • Project Monitoring/Governance
  • Commissioning & Qualification
• Prepare/perform/review process engineering drawings, and calculations, whether as part of engineering design or as part of verification of calculations of vendors/clients/other consultants. Drawings may include PFDs, P&IDs as well as others. Calculations may include heat exchanger, pump, piping, control valve sizing, heat, and mass balances, as well as other engineering calculations.
• Prepare/review technical specifications and data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc).
• Review technical documentation such as SDS/HDS, layouts, manuals, and datasheets.
• Manage other engineering design firms, equipment vendors, construction firms, and internal/external stakeholders as required to execute projects.
• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).
• Prepare/review User Requirements Specifications (URS)
• Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.
• Prepare/review automation sequences, as required for Process Automation, such as Functional Specifications, Valve & Alarm Matrices.
• Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be required for meetings with, clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable.
• Visit construction and installation sites.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by the client, based on workload and project requirements.

Qualifications

• Ability to lift 50 lbs.
• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience:
  • 3+ years of process engineering experience in pharma/biotech or in core biopharmaceutical unit operations (upstream or downstream).
• Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, and Change Controls.
• Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Basic knowledge of AutoCAD is an asset.
• Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.
• French Fluency is a must

Additional Information

We are an equal-opportunity employer.

Nous sommes à la recherche d'un(e) Conseiller(ère) en Assurance qualité pour aider à maintenir les normes de système qualité élevées de nos clients oeuvrant dans le domaine de production du cannabis.

Votre mission sera d'agir comme référence en matière de contrôle qualité au sein de notre équipe où tu auras la responsabilité de faire évoluer la culture qualité de l'entreprise.

Responsabilités principales :

• Planifier, mettre en place et maintenir un système de gestion de la qualité en accord avec les normes et réglementations de Santé Canada
• Assurer la conformité des procédures de production, des pratiques de laboratoire et de la documentation
• Coordonner les audits internes et externes en matière de qualité et participer à la gestion des évaluations de conformité
• Collaborer avec les équipes de production pour résoudre les problèmes de qualité et recommander des solutions pour améliorer les processus
• Élaborer et dispenser des formations pour les employés afin de s'assurer que les normes de qualité sont bien comprises et respectées
• Gérer les systèmes de traçabilité pour suivre les produits de leur point d'origine à leur destination
• Assurer la conformité des étiquettes des produits avec les exigences réglementaires de Santé Canada
• Maintenir et mettre à jour les documents relatifs à l'assurance qualité
• Participer à la gestion des plaintes des clients et à l'investigation des problèmes de qualité
• Être la référence en assurance qualité
• Être un acteur de changement et d'innovation pour la vision de l'assurance qualité
• Assurer une excellente collaboration avec les parties prenantes

Qualifications requises :

• 3+ année d'expériences en qualité, conformité ou affaires réglementaires, sécurité alimentaire et/ou domaine connexe
• Bac en sciences, chimie, agroalimentaire dans un programme lié à la qualité, la réglementation, la sécurité alimentaire ou tout autre domaine connexe
• Connaissance des normes et réglementations de Santé Canada
• Expérience préalable en assurance qualité, de préférence dans le secteur pharmaceutique, du cannabis ou de la production alimentaire
• Excellentes compétences en communication écrite et verbale en français et en anglais
• Capacité à travailler de manière autonome et en équipe
• Capacité à résoudre les problèmes de manière créative
• Capacité à gérer plusieurs projets simultanément et à respecter les échéances
• Capacité à maintenir des normes élevées de confidentialité et d'intégrité

Conditions de travail

• Bilingue: Français et Anglais
• Travail en entreprise et télétravail (mode Hybride)
• Être disponible à voyager occasionnellement

Description

The Quality Control Specialist will act as a Consultant and is responsible for planning and executing Quality Control deliverables while overseeing and evaluating the work performed by pharma product supplier and providing mentoring to our customer Quality staff. This role requires advanced knowledge and experience in QA, QC, Validation, Health Canada and FDA regulations, laboratory standards and industry standards for pharmaceutical production and Supplier facility with a strong understanding of GMP.

Principal Duties and Responsibilities :

Annual Product Review Program

• Establish and execute APR Program in collaboration with all relevant GMP controlled functions
• Execute and maintain Annual Program Schedule and ensure adherence to the assigned timelines for customer and CMO manufactured products
• Drive an effective assessment of the products compliance overview, identify concerning trends and issues
• Ensure communication with the product owner and supplier of the identified issues and an oversight of the Corrective and Preventive Actions associated with the outcome of the APR Program reflecting CAPA effectiveness in the next year APR
• Employ an effective electronic solutions for optimization of the data consolidation towards APR execution

Change Control Management Program

• Initiate and approve Change Management process at the supplier site as per Quality Policy requirements
• Ensure appropriate Change ownership and timely execution of the Change Control records with the customer and the supplier
• Design and develop Change Management training for the key Change Owners from GMP regulated functions
• Support design and development of the robust electronic solution supporting the Program effectiveness
• Consult the functions on the change management, execution and risk-based impact assessment process

Stability Program

• Lead all the activities associated with management of the Stability Program at the customer site
• Manage development of the Stability Program Protocols and Reports
• Ensure timely placement and retrieval of the samples from the stability chambers and their transfer to the QC testing laboratories
• Manage Stability Program Database
• Consistently strive towards improvement of the Stability Program effectiveness
• Ensure that the customer is compliant to the processes associated with Documentation management and control ( Test Methods, Specifications, SOPs etc.).
• Ensure harmonization of processes and best practice of Quality Systems between our customer and the supplier
• Oversee the review and trending of Quality Metrics, including the monitoring and reporting of Key Performance Indicators
• Participate in Internal, Customer, Supplier and Regulatory Audits
• Develop SOPs as required
• Other duties as assigned

Knowledge, Skills and Abilities

• Minimum of B.Sc. Chemistry or other associated field
• Minimum 5 years’ experience in the pharmaceutical industry
• Member of Ordre des chimistes du Québec
• Experience in Regulatory inspection management
• In depth knowledge of the pharmaceutical industry
• In depth of GMP, FDA, HPFBI Regulatory requirements and the associated guidelines
• Excellent organizational skills and multi-tasking ability
• Excellent written and verbal skills
• Demonstrated ability to work in a team environment
• Excellent interpersonal and negotiating skills
• Experience in dealing directly with Regulatory Agency officials (Health Canada, USFDA)
• Sound knowledge and application of Health Canada and FDA regulations
• Strong statistical, trending and risk analysis skills

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be available to travel occasionally

Job Summary

The Compliance and Quality Assurance Specialist will act as a Consultant and is responsible for planning and executing Quality Assurance deliverables while overseeing and evaluating the work performed by the pharm product supplier and providing mentoring to the Quality Assurance staff. This role requires advanced knowledge and experience in API and CMO quality assurance, Health Canada and FDA regulations, laboratory standards and industry standards in the API production and CMO facility with a strong understanding of GMP.

Areas of Responsibilities

• Review and execute Quality Management Systems (QMS)
• Develop and manage policies, procedures, work instructions, Deviation, CC and CAPA
• Investigate quality concerns; resolve and follow-up on corrective actions
• Monitor, evaluate quality indicators, QA reports and audit responses
• Submit change notification/application to applicable authority
• Set specifications foe substance, materials and intermediates
• Perform in-process and Batch review
• Prepare reports on OOS, critical deviation
• Provide test procedure, quality statements, stability reports, and other documents
• Perform annual Product Quality Review (APQR)

Qualification

• A degree in Chemistry, Biology, Pharmacology or Food Science
• Member of Ordre des chimistes du Québec
• 3+ years experience in Quality Assurance/Control in GxP Regulated industries
• Strong knowledge of GMP, QMS, QRM, Lean Manufacturing & Validation Principles

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be available to travel occasionally

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Responsibilities

As a Qualification Validation Specialist, you will act as a Consultant on a remote and/or hybrid mode engagement opportunity.

Duties and responsibilities include, but are not limited to:

• Creating qualification (IQ/OQ/PQ) test protocols.
• Ensuring documentation aligns with URS and PPQ plan.
• Preparing and executing validation documents.
• Project execution for multiple systems validation.
• Understanding the hours budgeted for completion of each task on a specific.
• Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
• Develop Installation, Operational and simple Performance qualification documents.

Requirements

• Qualified candidates will possess a Bachelor’s degree in related field along with 3 plus years related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Strong understanding GxP (US FDA, Health Canada, EMA, etc.) requirements
• Experience with temperature mapping.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• Must be willing to travel

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be able to travel occasionally

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