QAV Engineer
Listed on 2026-10-27
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description:
We are seeking an experienced QAV Engineer to support a pharmaceutical client in Boston, MA. The ideal candidate will have a strong background in Quality Assurance, equipment qualification, and validation within a GMP-regulated manufacturing environment.
Key Responsibilities:- Perform quality engineering activities and remediate compliance gaps within GMP facilities.
- Initiate, manage, and own CAPAs to address quality and compliance issues.
- Execute installation verification, functional testing, equipment qualification, and performance qualification (PQ).
- Support validation activities for cold storage, autoclaves, and warehouse operations.
- Develop, execute, revise, and review validation protocols, plans, SOPs, and reports.
- Review lifecycle documentation, including URS, design documents, risk assessments, impact assessments, Part 11 assessments, and traceability matrices.
- Investigate and remediate quality events related to qualified equipment.
- Assess change controls for validation impact and support decommissioning activities.
- Review and approve validation plans, protocols, and reports.
- Collaborate with engineering teams, SMEs, and cross-functional stakeholders to maintain GMP compliance and documentation.
- Bachelor’s degree in Engineering, Science, or a related discipline.
- Minimum 3 years of experience in GMP manufacturing facilities.
- Mandatory experience in Oral Solid Dosage (OSD).
- Hands-on experience with commissioning, qualification, and validation (CQV) of facilities, utilities, production, laboratory, or support equipment.
- Strong knowledge of validation lifecycle management, risk-based validation, and cGxP requirements.
- Experience with equipment qualification, process validation, computer systems validation, cleaning validation, or sterilization.
- Knowledge of FDA, cGMP, ICH, ISO, EMA, ISPE, and PDA guidelines.
- Strong communication, documentation, and cross-functional collaboration skills.
Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:
Health Insurance:Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits:A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO):No PTO is provided other than that required by applicable state and local laws.
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