This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is fully on-site in Boston.

Position Summary:The Validation Engineer will be responsible for executing Commissioning, Qualification, and Validation (CQV) activities in support of a Cell and Gene Therapy manufacturing environment. This role involves collaboration across departments and flexibility to support multiple validation initiatives in a dynamic setting.

Key Responsibilities:

• Develop and implement Quality System documentation to establish robust validation practices.

• Author and execute URS, IQ, OQ, and PQ protocols in alignment with GDP guidelines and internal quality standards.

• Support qualification efforts for analytical instruments, automated manufacturing equipment, and facility systems.

• Perform analytical instrumentation qualifications in accordance with USP <1058> and internal procedures.

• Conduct automation and computer system validation (CSV) assessments to ensure compliance with 21 CFR Part 11 and relevant regulatory standards.

• Coordinate with vendors to schedule and execute validation and test plans.

• Work collaboratively with internal teams to ensure safe and efficient execution of CQV activities.

• Provide validation support for process changes and ongoing improvement initiatives.

• Contribute to process validation activities including aseptic process simulations (APS), process performance qualifications, and material qualifications.

• Develop and validate sterilization cycles as applicable.

• Support Environmental Monitoring Performance Qualification (EMPQ) activities as needed.

• Maintain compliance with training requirements and ensure all validation activities meet SOPs, global standards, and cGMP guidelines.

• Uphold a “right-the-first-time” documentation approach and promote strong cross-functional partnerships.

Ideal Candidates Will Have:

• 2+ years of relevant validation experience in GMP manufacturing or analytical laboratory settings; early-career professionals with strong foundational knowledge are encouraged to apply.

• Solid understanding of Computer System Validation (CSV) principles and regulatory requirements.

• Experience or familiarity with Environmental Monitoring Performance Qualification (EMPQ) is a plus.

• Exposure to equipment and process validation is preferred.

• Ability to manage multiple priorities and shift between projects based on evolving needs.

• Adaptability, attention to detail, and a proactive mindset in a fast-paced, regulated environment.

• Bachelor’s degree in Engineering, Life Sciences, or a related field, or equivalent practical experience.

• Working knowledge of GMP, ISO, GAMP, and ANSI standards.