Senior CQV Engineer

Senior CQV Engineer

Client:
Biotechnology company

Contract duration: 18-month contract (strong possibility of extension)

Location:

Toronto

Pay Rate: $70-80 /hr

The Senior CQV Engineer will be based at our biotech client’s new Toronto site. This project is the relocation of all Toronto based groups (GMP Manufacturing, AD&QC, Research, Device Development, Process Development) from two locations in Toronto into three unfinished floors in a brand-new life science built facility. This role will lead the CQV execution of admin areas, research labs, QC labs, and Grade B Cell Therapy clean rooms.

The Senior CQV Engineer will be the main technical SME ensuring that two CQV firms properly design and execute the commissioning, qualification, and validation of the facility. Actual execution of protocols is not expected from the engineer. Instead, the individual will oversee executions, in person, and be the main reviewer, approver, and problem solver of CQV issues. This position reports to the Director of CQV and Engineering.

This is an anchor position in Toronto, ON. There will be flexibility with work hours and on-site presence; however, expectation is that the employee is at the facility 5 days a week. The CQV Engineer must excel in a fast-paced environment, being able to handle significant workload with limited oversight, and will engage with all technical (Research, Process Development, Manufacturing, MSAT, QA, QC, Tech Transfer) and non-technical departments (Supply Chain, Procurement, Office Management) as it relates to CQV efforts for the facility and equipment.

Additionally, this position will interface with multiple 3rd parties including engineering, construction, and CQV firms.

• Oversee development of impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct and no impact systems and functions within complex processes.
• Maintaining (and ensuring the larger team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.
• Oversee the authoring, editing, and execution of technical commissioning, qualification and validation documentation for standard equipment/systems/ software, under guidance of the CQV/ENG Director.
• Make recommendations for design or process modification based on test results when executing test scripts.
• Adherence with project schedule for all assigned activities.
• Provide CQV subject matter expertise for MEP systems (HVAC, gases, chilled water, cold rooms etc.).
• Partner with EHS to ensure safety is embedded throughout the CQV process.
• Ensure adherence to regulatory and corporate CQV policies and standards.
• Provide guidance to junior members of the project team.
• Represent the company’s interests interfacing with project vendors and the landlord.

• Recent experience bringing a GMP manufacturing facility to completion, ideally a facility with Grade B spaces.
• Experience with Phase 1 or 2 clinical manufacturing is an added bonus.
• BSc in Engineering or related life science degree with 5+ years of engineering experience, or 10+ years of relevant experience in Biotech/Pharma facilities.
• Extensive knowledge of equipment, automation, and facilities used in pharmaceutical manufacturing of cell culture and CGT materials.
• Experience with cGMP manufacturing, BSL2/CL2 clean rooms, and regulatory agency inspections.
• Experience commissioning and qualifying mechanical HVAC, building controls, GMP, and non-GMP assets.
• Experience working with CQV software (i.e. Kneat), CMMS and QMS.
• Excellent interpersonal skills to effectively communicate with a diverse, wide customer base.
• Excellent planning and organizational skills.
• Advanced oral and written communication skills.
• High level of urgency and ability to quickly adapt to changing priorities.
• Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.

In this position you will work in a controlled laboratory environment and construction zone. There is a risk of potential exposure to chemicals and biohazards consistent with somatic cell therapy culture. Working in the laboratory/ construction area requires mandatory use of personal protective equipment. Weekend and off-hour work on an as-needed basis will be required. Travel to equipment manufacturers for FATs is expected.