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
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 Scope
Assigned 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.
