CQV Specialist

Full-Time, Onsite
Quebec, QC, Toronto, ON
Posted 1 month ago

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.

Job Features

Job CategoryContract, Permanent

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