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.

GENERAL POSITION SUMMARY:

The Validation Engineer will be actively involved in Commissioning, Qualification, Validation (CQV), and Requalification activities for Cell and Gene Therapy facilities. This individual will be responsible for executing qualification protocols and collaborating with cross-functional teams including Engineering, Facilities Operations, IT, Quality Assurance, and Project Management throughout the project lifecycle.

This position reports to the Validation Manager.

KEY RESPONSIBILITIES:

Responsibilities may include, but are not limited to:

• Develop and execute qualification and validation test plans and protocols.

• Ensure all validation documents comply with current Standard Operating Procedures (SOPs), global standards, and current Good Manufacturing Practices (cGMP).

• Coordinate with onsite personnel and vendors to schedule and execute test plans.

• Collaborate with construction and operations teams to schedule and conduct validation activities safely and efficiently, when required.

• Work effectively with cross-functional stakeholders including Project Management, IT, Environmental Health & Safety, Security, Design Teams, and Quality Assurance.

• Complete required training and maintain 100% compliance at all times.

• Promote a “right-the-first-time” approach for all documentation.

• Foster positive relationships and collaboration across functional teams.

MINIMUM QUALIFICATIONS:

• Adaptable to change and able to quickly adjust to shifting priorities.

• Bachelor’s degree in Engineering (Chemical, Biomedical, Industrial, Biotechnology) or a related discipline.

• 2–4 years of experience in CQV or equivalent professional experience in a regulated environment.

• Ability to work independently with minimal supervision.

• Experience in developing and executing validation protocols in a GMP-regulated industry.

• Familiarity with using validation tools such as Kaye Validator and data loggers.

• Knowledge of applicable technical standards and guidelines (e.g., GMP, ISO, GAMP, ANSI).

• Strong problem-solving and troubleshooting abilities.