Senior CQV Engineer Validation Lead

Validation & Engineering Group Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.

We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:

• Senior CQV Engineer / Validation Lead

Position Summary

The Senior CQV Engineer / Validation Lead will be responsible for the planning authoring execution and completion of Commissioning Qualification Validation (CQV) and Process Qualification activities associated with laboratory manufacturing and process equipment. This is a hands-on role requiring the individual to independently develop validation documentation execute qualification protocols manage deviations analyze results and prepare final reports while coordinating activities with Engineering Manufacturing and Quality teams.

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

Primary Responsibilities

Validation Planning & Risk Assessment

• 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.

Protocol Authoring

• 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.

Protocol Execution

• 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.

Deviation Management & Final Reporting

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

Process Qualification & Characterization

• 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.

Documentation Support

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

Specific Activities Included in Scope

The resource may be required to author execute and report on activities such as:

• Desktop Printer IOQ
• Flat Box Labeler IOPQ
• CalCheck IOQ
• Tube Labeler FAT and IOQ
• SureTorque IOQ
• BioSafety 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.

Required Qualifications

• Bachelors Degree in Engineering Life Sciences or related technical discipline.
• Minimum 810 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 Change Controls.
• Strong technical writing skills.
• Ability to work independently with minimal supervision.

Preferred Experience

• AKTA Systems
• Bioreactors
• Biosafety Cabinets
• Lyophilizers
• Autoclaves and Washers
• Labeling Systems
• Filling and Capping Equipment
• Laboratory Instrumentation
• Calibration Systems
• Freezers and Controlled Temperature Equipment

Work Location

Remote Activities

• Validation Planning
• Risk Assessments
• Protocol Authoring
• URS Development
• SOP Development
• Batch Record Development
• Final Report Preparation
• Data Review and Analysis

On-Site Activities

• Equipment Walkdowns
• Protocol Execution
• FAT/SAT Support
• Field Verification
• Deviation Resolution
• Characterization Studies
• OQ/PQ Execution
• System Release Activities

At Validation & Engineering Group people always come first. We believe that when youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven supportive team.

Excited to build something meaningful together We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status.