CQV Engineer

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

What you will be doing:

• Draft and execute Commissioning and Qualification (C&Q) documentation and services for client facility, utility, process, and equipment (Manufacturing and QC Lab).
• Perform/execute the validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification and/or requalification.
• Author specifications, assessments, SOPs, and test protocols across a diverse Life Science market comprised of Pharmaceuticals, Biotechnology, Cell & Gene Therapy, and Medical Device clients.
• Assist in the development and implementation of Quality Management System (QMS) procedures, in harmony with regulatory standards such as 21 CFR Part 210 and 211 Part 11, ICH Q8, ICH Q9, and ICH Q10, and Annex 11.
• Prepare written validation reports with high level of detail and organization.
• Collaborate with teams to perform investigations, diagnose problems, and troubleshoot validation issues.
• Develop and complete deliverables related to CQV activities as needed to ensure objectives are met; manage project deliverables to agreed schedule and scope.
• Evaluate processes, propose solutions resolve issues and communicate results to support project/task completion.

What we are looking for:

• Bachelor’s or master’s degree in Bioengineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or other Science related technical degree preferred
• 6+ years of experience of validation in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry
• 4+ years of experience with authoring and executing validation protocols of manufacturing process equipment and QC lab equipment, automation/computerized systems, utilities and facilities, cleaning validation, and/or process validation
• Strong background in commissioning and qualification
• Experience in the areas of validation lifecycle documentation (URS, System Classification, Risk Assessment, Design Reviews), and Validation Protocols (IQ, OQ, PQ, PV, CSV, requalification/periodic reviews) etc.
• Experience with Quality Systems (handling Change Controls, Non-Conformances, Deviations, CAPAs)
• Strong communication and interpersonal skills with ability to interact with all levels of management, clients, vendors, cross-functional teams, etc.

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.