Validation Engineer

Job Title: 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