New

CQV Engineer (AIQ)

Digital Prospectors
United States, Massachusetts, Boston
230 Congress Street (Show on map)
Jun 12, 2025
Position:CQV Engineer (AIQ) Location:Boston, MA (Onsite) Length:6+ months W2 Candidates Only, without Sponsorship Job Description:* Our client is seeking a CQV Engineer (AIQ) to support Commissioning, Qualification, and Validation (CQV) activities at its cutting-edge manufacturing and analytical facilities. This role will play a key part in ensuring equipment and systems used in cell and gene therapy manufacturing meet stringent compliance and quality standards. The successful candidate will work cross-functionally to lead and execute validation efforts-particularly around analytical instrumentation qualification (AIQ)-in alignment with GMP, regulatory expectations, and internal procedures. Essential Duties and Responsibilities (but not limited to): Develop and implement validation and quality system documentation in accordance with good validation practices. Author and execute URS, IQ, OQ, and PQ protocols following GDP and internal quality standards. Lead and support qualification of analytical instruments and automated manufacturing equipment, including those used in medical device production. Perform AIQ in accordance with USP <1058> and internal SOPs. Conduct Automation Assessments to ensure 21 CFR Part 11 compliance. Coordinate test plan execution with vendors and internal stakeholders. Support process validation activities such as aseptic process simulations (APS), process performance qualification (PPQ), and material qualification. Develop and validate sterilization cycles as required. Ensure all validation activities are performed in compliance with SOPs, cGMP, and global standards. Promote accuracy and compliance through a right-the-first-time approach in documentation and execution. Complete assigned training and maintain 100% compliance. Qualifications: Bachelor's degree in Engineering or a related scientific field, with 3-8 years of relevant validation experience (or equivalent). Demonstrated ability to safely perform validation activities in a fast-paced, regulated environment. Experience executing validation protocols in GMP manufacturing and analytical lab settings. Flexible and responsive to evolving project needs and priorities. Strong understanding of GMP, GAMP, ISO, ANSI, and other applicable validation and regulatory frameworks. Collaborative team player with a proactive, solutions-oriented mindset. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. Come see why DPC has achieved: 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor. Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine. As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today! www.LoveYourJob.com