TRC's client is an established life sciences consulting group looking for a Senior CQV Engineer as a full-time, direct hire placement in the Boston, MA region.

What you will be doing:
• Generate and execute life cycle documentation (FAT, SAT, CTP, DQ, IOQ, PQ) for facilities, utilities, manufacturing/QC lab equipment (cell culture, protein purification, cell and gene therapy, fill-finish) computer systems, automation and processes (cleaning, sterilization, shipping) for qualification/requalification.
• Write, review and revise a variety of Commissioning and Qualification protocol related documents, including but not limited to SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design review, or other technical documents.
• Write procedures, investigations, change controls, etc. to support the validation lifecycle documentation; write summary reports to summarize Commissioning and Qualification testing.
• Develop and execute validation... plans and protocols for Process Performance Qualification (PPQ), mixing validation, L&E, materials qualification and other manufacturing processes.
• Perform P&, installation and operational tests for equipment and utilities. Perform thermal mapping of temperature controlled chambers, (refrigerator, freezers, incubators, cryo storage) warehouses, and SIP processes.
• Provide assistance with project management for mid to complex size projects for commissioning, qualification of new engineering systems and facilities.
• Collaborate well with the cross-functional team and work efficiently in a team environment. Communicate effectively with management, stakeholders, regulatory agencies and vendors. Assist in providing training to other engineers in the team.

What we are looking for:
• 5+ years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, cell and gene or medical device industry
• Experience in the Fill Finish and Media Fill sector required
• Hands on experience in executing C&Q protocols for facilities, utilities and manufacturing/ QC lab equipment and processes.
• Experience in Quality or QAV is desired.
• Strong knowledge of FDA, EU and cGMP regulations and good documentation practices
• Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams

What we offer:
• Competitive Pay
• Flexible PTO
• Training and Development Opportunities
• Medical, Dental, and Vision Benefits
• 401(k) Matching
• Substantial Bonus Opportunities
• Volunteer Paid Time Off
• Paid Holidays
• Diversity and Inclusion Initiatives
• Employee Recognition Program
• Paid Travel and Expense Reimbursement

TRC Staffing is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law
Cambridge ON

Salary Criteria