Job DescriptionCQV Engineer - Cell and Gene Therapy EquipmentLocation: Princeton, NJ
Work Type: 100% Onsite
Schedule: Full-Time
Start Date: To Be Confirmed
Join Our Team: Full-time, W2 CQV Engineer with Pioneer GMP Consulting.
First Client Engagement: Onsite in Princeton, NJ, supporting cell and gene therapy equipment qualification
Worth Authorization: Must Be Authorized to Work in the United States; Sponsorship Is Not Available
What You'll Do- Develop commissioning and qualification plans, protocols, test scripts, reports, and supporting documentation
- Execute commissioning and qualification activities for equipment used in cell and gene therapy manufacturing
- Generate, review, execute, and summarize IQ, OQ, PQ, commissioning, and requalification activities, as applicable
- Perform equipment walkdowns, field verification, functional testing, and documented inspections
- Verify equipment installation, configuration, operating parameters, alarms, interlocks, controls, and functionality
- Review equipment specifications, drawings, P&IDs, vendor manuals, turnover packages, and design documentation
- Review and leverage FAT, SAT, startup, commissioning, and vendor testing documentation when appropriate
- Prepare qualification-summary reports documenting test results, discrepancies, resolution, and final conclusions
- Document and resolve protocol discrepancies, deviations, exceptions, punch-list items, and open actions
- Support investigations, change controls, corrective actions, and quality-risk assessments associated with CQV activities
- Maintain traceability between requirements, risks, testing, objective evidence, discrepancies, and final conclusions
- Coordinate field execution with Engineering, Manufacturing, Quality, Validation, Automation, contractors, and equipment vendors
- Support equipment startup, system turnover, operational readiness, and transition into routine GMP use
- Track assigned systems, protocols, open actions, documentation status, risks, and schedule commitments
- Maintain complete, accurate, traceable, and inspection-ready CQV documentation
- Support audits and inspections by retrieving records and explaining qualification strategies and results
- Perform all work in accordance with approved procedures, safety requirements, cGMP expectations, and good documentation practices
- Represent Pioneer with professionalism, technical credibility, sound judgment, and accountability
Anticipated Equipment ScopeAssigned equipment may include systems used in cell and gene therapy manufacturing and associated GMP operations, such as:
- Manufacturing and process equipment
- Single-use processing equipment
- Biosafety and aseptic-processing equipment
- Laboratory and quality-control equipment
- Controlled-temperature equipment
- Equipment automation and computerized interfaces
- Supporting facility and utility connections associated with assigned equipment
Final equipment assignments will be based on project needs.
Required Qualifications- At least five years of commissioning, qualification, validation, equipment-engineering, or related experience within GMP-regulated pharmaceutical, biotechnology, biologics, or advanced-therapy manufacturing
- Hands-on experience generating and executing commissioning and qualification documentation
- Experience preparing protocols, test scripts, discrepancy documentation, and qualification-summary reports
- Experience executing IQ, OQ, PQ, commissioning, or requalification activities
- Experience performing field verification and functional testing of GMP manufacturing or laboratory equipment
- Working knowledge of cGMP requirements, good engineering practices, and good documentation practices
- Understanding of risk-based commissioning and qualification principles
- Ability to review technical specifications, drawings, P&IDs, equipment documentation, and vendor test packages
- Experience documenting and resolving deviations, protocol exceptions, discrepancies, and punch-list items
- Strong technical-writing, documentation-review, organization, and problem-solving skills
- Ability to work effectively with Engineering, Manufacturing, Quality, Validation, Automation, contractors, and equipment vendors
- Ability to independently manage assigned equipment and deliverables with limited supervision
- Ability to work onsite in Delaware based on the project execution schedule
- Bachelor's degree in engineering, life sciences, or a related technical discipline, or equivalent relevant industry experience
What Will Set You Apart- Direct experience qualifying equipment used in cell and gene therapy manufacturing
- Experience supporting biologics, viral-vector, aseptic-processing, or other advanced-therapy operations
- Experience with single-use manufacturing systems
- Experience supporting facility startup, expansion, technology transfer, or operational-readiness programs
- Experience participating in FAT, SAT, equipment startup, commissioning, and system-turnover activities
- Experience assessing equipment automation or computerized functions in coordination with Automation or CSV teams
- Prior CQV consulting, contract, or staff-augmentation experience
- Experience entering an active project and becoming productive with minimal ramp-up time
Key Details- This is a hands-on CQV role requiring direct field execution and detailed documentation.
- The work is expected to be performed onsite in Delaware five days per week.
- Candidates must live within commuting distance or independently establish a local presence before the engagement begins.
- Project schedules may occasionally require adjusted hours during critical execution periods.
- The initial engagement is expected to last approximately three to six months but may be extended, shortened, delayed, or changed.
- Final equipment assignments, timing, and project requirements will be confirmed as client planning progresses.
