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

Note :

• Need Local to MA with same State Id 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 clients 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:

• Bachelors 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.