CQV Specialist

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.