CQV Engineer III

Lead commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, systems (FUSE), and analytical instruments.

Develop and execute validation strategies for complex systems and capital projects.

Author and approve lifecycle validation documentation including risk assessments, IQ/OQ/PQ protocols, and summary reports.

Lead deviation investigations, perform root cause analysis, and drive CAPA development and implementation.

Perform and approve change control impact assessments and implementation plans to maintain validated state.

Serve as a subject matter expert (SME) during internal and external regulatory inspections.

Drive continuous improvement initiatives within the CQV program to enhance compliance and operational efficiency.

Influence validation strategy and site compliance decisions through strong technical expertise.

Lead complex or high-risk validation projects with minimal oversight.

Provide technical mentorship to junior CQV engineers and contribute to department-level improvements.

Independently resolve complex technical and compliance issues in alignment with validation lifecycle principles and regulatory requirements.

Apply advanced technical writing and documentation review skills to ensure high-quality, inspection-ready deliverables.

Collaborate cross-functionally to remove barriers, accelerate project execution, and strengthen validation excellence.

Leverage digital tools and data-driven approaches — including exposure to advanced analytics and emerging generative AI technologies — to modernize validation practices and maximize patient impact.

Bachelor of Science in Engineering (Chemical or Mechanical preferred; other scientific disciplines considered).

5+ years of experience in biopharmaceutical validation, CQV, engineering, or related cGMP manufacturing roles.

Strong understanding of validation lifecycle principles and global regulatory requirements.

Demonstrated ability to lead complex validation efforts and capital projects.

Advanced technical writing and documentation review skills.

Proven ability to independently resolve complex technical and compliance issues.

Strong cross-functional leadership and communication skills.

Must hold work authorization in the United States and be able to maintain that status without the need for future sponsorship.

Ability to operate independently with minimal oversight.

Ability to lead complex or high-risk validation projects.

Ability to influence validation strategy and site compliance decisions.

Ability to mentor junior engineers and contribute to department-level improvements.

Bachelor's Degree

Approximately 5% travel to Norwood, MA. Employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law, implying U.S. person status. Candidates must already hold work authorization in the United States and be able to maintain that status without the need for future sponsorship.