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 support Commissioning, Qualification, and Validation (CQV) activities for a Cell and Gene Therapy facility. This role focuses on equipment validation while also supporting process validation initiatives as needed. Flexibility to manage shifting priorities and multiple projects is essential.

Key Responsibilities:

• Draft and implement Quality System documentation to establish good validation practices.

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

• Lead and support qualification efforts for analytical instruments, automated manufacturing equipment, and facility systems, with a primary emphasis on equipment validation.

• Perform Analytical Instrumentation Qualifications in accordance with USP <1058> and applicable SOPs.

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

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

• Collaborate with vendors to schedule and execute test plans, as required.

• Work with internal stakeholders to safely and efficiently schedule CQV activities.

• Author or support documentation related to process validation, including process performance qualifications and material qualifications.

• Develop and validate sterilization process cycles, as applicable.

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

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

Ideal Candidates Will Have:

• Strong background in equipment validation (process validation experience is a plus).

• Working knowledge of Computer System Validation (CSV) principles; this is critical for success in the role.

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

• Familiarity with process changes and validation support for improvement initiatives.

• Demonstrated experience developing and executing validation protocols in GMP manufacturing and analytical laboratory environments.

• Bachelor’s degree in Engineering, Life Sciences, or related discipline with 4+ years of validation experience (or equivalent professional background).

• Knowledge of GMP, ISO, GAMP, and ANSI standards.

• Adaptability, attention to detail, and the ability to thrive in a fast-paced, regulated setting.