Urgent On-Site Opening for Senior CQV Engineer - Needham, MA - Need Local to MA Only.

Job Description

Job Description

Note :

• Need Local to MA, with same State I’d Only.

Position Overview :

• Need someone with Lab experience.
• We are looking for 4 Senior Commissioning, Qualification, and Validation (CQV) Engineers to perform execution of lab equipment qualification (LEQ) and facility/environmental utility (FEU) commissioning activities to support the reactivation and GMP-readiness of a Boston area client’s QC Laboratory.
• This role will focus on drafting and executing URS, IQ, OQ, PQ, and commissioning protocols, ensuring equipment, utilities, and lab spaces are compliant with FDA/EMA requirements and fully audit-ready within a compressed five-week timeline.
• Ideally, all candidates will be capable of working cross functionally on both equipment and the facility systems, however in terms of focus we will need two QAV engineers to handle the equipment validation and 2 Commissioning Engineers to handle the FEU validation.

Tasks, Responsibilities, and Deliverables:

• Develop and execute URS for lab equipment and utilities (balances, centrifuges, incubators, freezers, biosafety cabinets, HVAC, gases, freezer room).
• Draft and execute commissioning protocols for FEU systems.
• Perform and document IQ, OQ, and PQ for lab instruments and support equipment.
• Conduct criticality assessments to determine validation scope and depth.
• Support traceability matrix development to ensure requirements coverage.
• Document test execution results, deviations, and corrective actions.
• Prepare and finalize GMP-ready validation reports for submission to QA.
• Interface with Client SMEs and QA for review/approval cycles, ensuring alignment with site standards.
• Deliver assigned packages within agreed milestones to enable regulatory readiness.

Required Skills, Scope, and Experience:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 8+ years’ experience in commissioning, qualification, and validation within GMP-regulated biopharma/biotech environments.
• Strong knowledge of FDA, EMA, and ICH requirements, including 21 CFR Parts 210, 211.
• Demonstrated expertise in IQ/OQ/PQ execution for QC lab instruments and utilities.
• Experience with commissioning HVAC, environmental monitoring systems (EMS), and building management systems (BMS).
• Familiarity with risk-based validation (ISPE Baseline Guides, ASTM E2500).
• Strong technical writing and documentation skills (URS, protocols, reports).
• Ability to deliver results under compressed timelines with high compliance standards.