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 junior engineers, and resolve design-related issues. We strongly encourage chemical engineers/process engineers with any bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.
Responsibilities
Provide technical guidance on 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 the verification of calculations of vendors/clients/other consultants. Drawings may include PFDs, P&IDs, and 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, and project updates.
- – Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and 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.