Senior CQV Engineer​/Validation Lead

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier providing solutions in Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries across Laboratory, Compliance, Computer, Engineering, Project Management, Validation and related services.

We are seeking a dedicated individual for the following position.

The Senior CQV Engineer / Validation Lead will plan, author, execute and complete Commissioning, Qualification, Validation (CQV) and Process Qualification activities across laboratory, manufacturing and process equipment. The role is hands‑on, requiring independent development of validation documentation, execution of qualification protocols, deviation management, result analysis, final reporting and coordination with Engineering, Manufacturing and Quality teams.

The resource will support qualification of laboratory instrumentation, biosafety cabinets, labeling systems, filling and capping equipment, process equipment, bioreactors, AKTA systems, freezers, lyophilizers, autoclaves, washers and associated manufacturing systems.

• Develop Validation Plans and Qualification Strategies for assigned systems.
• Conduct System Impact Assessments (SIA) and Risk Assessments.
• Define CQV deliverables, acceptance criteria and testing approaches.
• Participate in project planning meetings and provide technical CQV guidance.
• Maintain document tracking systems and status reports for validation deliverables.

• Independently author and revise:
  • FAT Protocols
  • SAT Protocols
  • IQ Protocols
  • OQ Protocols
  • PQ Protocols
  • IOQ Protocols
  • Validation Summary Reports
  • Qualification Traceability Matrices
• Generate User Requirement Specifications (URS) when required.
• Develop test scripts, data sheets and supporting qualification documentation.
• Route documents through review and approval cycles.

• Execute IQ, OQ, PQ and IOQ protocols in the field.
• Perform equipment walkdowns and field verification activities.
• Coordinate testing with Engineering, Manufacturing, Vendors and Quality.
• Document test results and supporting evidence.
• Support FAT and SAT activities as required.
• Ensure all testing is performed in accordance with approved protocols and GMP requirements.

• Identify, document, investigate and resolve deviations encountered during qualification activities.
• Support CAPAs and Change Controls affecting qualified systems.
• Analyze qualification results and assess acceptance criteria.
• Author final qualification reports and validation summary reports.
• Support system release into GMP operation.

• Perform characterization studies and process qualification activities.
• Support qualification of:
  • Filling systems
  • Capping systems
  • Cap inspection systems
  • Labeling systems
  • Check‑weighing systems (including Gage R&R activities)
  • Complete fill‑line process operations
  • Generate and execute OQ and PQ protocols.
  • Compile and analyze process qualification data.

• Develop and revise equipment SOPs.
• Develop and update manufacturing batch records.
• Ensure compliance with GMP documentation practices and site procedures.

• Desktop Printer IOQ
• Cal Check IOQ
• Tube Labeler FAT and IOQ
• Bio Safety Cabinet IOQ
• Filling Line Characterization
• Capping System Characterization
• Labeling System Qualification
• Check Weighing System Qualification and Gage R&R
• LTP Line OQ and PQ Generation
• LTP Line OQ and PQ Execution
• Final Qualification Reporting
• Equipment SOP Development
• Batch Record Development

These activities are based on the currently identified CQV work packages and may be adjusted as project priorities evolve.

• Bachelor’s Degree in Engineering, Life Sciences or related technical discipline.
• Minimum 8–10 years of CQV, Validation, Qualification or Process Validation experience within pharmaceutical, biotechnology or medical device environments.
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols.
• Strong knowledge of GMP regulations, FDA guidance, ASTM E2500, GAMP and ISPE methodologies.
• Experience managing deviations, investigations, CAPAs and…