Validation Engineer

Validation Engineer

Location: Boston/Cambridge, MA

Industry: Cell & Gene Therapy / Life Sciences

Job Description: We are seeking a Validation Engineer to support qualification, requalification, and validation activities within a GMP-regulated Cell and Gene Therapy facility. This role will focus on ensuring facilities, utilities, equipment, and systems meet applicable quality and regulatory requirements.

Responsibilities:

• Develop, review, and execute validation and qualification protocols, plans, and reports
• Support requalifications, periodic assessments, and CQV projects
• Qualify facilities, utilities, laboratory equipment, and manufacturing systems
• Perform risk and impact assessments as needed
• Collaborate with Engineering, QA, EHS, Project Management, and other cross-functional teams
• Coordinate vendors supporting validation activities
• Ensure compliance with cGMP, SOPs, GAMP, ISO, CFR, and applicable standards
• Support continuous improvement and right-first-time documentation practices

Requirements:

• Bachelor's degree in Engineering or a related technical field
• 3–8 years of Validation/CQV experience in a GMP environment
• Experience writing and executing qualification protocols
• Knowledge of GMP, CFR, ISO, GAMP, and related standards
• Strong technical problem-solving and communication skills
• Ability to work independently and adapt to changing priorities

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan