CQV Engineer (AIQ)
Boston, MA
Job Type: Contract | Recruiter: Christie Spencer | Phone: 603.609.7082
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.
- 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.
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.
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