Validation Engineer
inSync Staffing
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:
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
- 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
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
Vacancy posted 15 hours ago
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