CQV Engineer (Princeton, NJ)

Pioneer GMP Consulting•Princeton, NJ

1d•Onsite

About The Position

Pioneer GMP Consulting is seeking an experienced CQV Engineer for a client engagement supporting equipment used in a GMP-regulated cell and gene therapy manufacturing environment. This is a hands-on execution role involving the development, execution, and summarization of commissioning and qualification activities for manufacturing, laboratory, and supporting equipment. The engineer is expected to manage assigned equipment independently from planning and protocol development through field execution, discrepancy resolution, and final reporting. The position is described as full-time, W2, and onsite. The posting names Princeton, New Jersey in the role heading and client-engagement description, but later states that the work will be onsite in Delaware five days per week and refers to working onsite in Delaware. The first engagement is expected to last approximately three to six months, with the possibility of extension, shortening, delay, or changes. Candidates must live within commuting distance or establish a local presence before the engagement begins. Project schedules may occasionally require adjusted hours during critical execution periods. Assigned equipment may include manufacturing and process equipment, single-use processing systems, biosafety and aseptic-processing equipment, laboratory and quality-control equipment, controlled-temperature equipment, equipment automation and computerized interfaces, and supporting facility and utility connections. Final assignments and project requirements will depend on client needs. The consultant will coordinate with client Engineering, Manufacturing, Quality, Validation, Automation, contractors, and equipment vendors. The role also supports startup, system turnover, operational readiness, routine GMP use, audits, and inspections. Work must follow approved procedures, safety requirements, cGMP expectations, and good documentation practices.

Requirements

At least five years of commissioning, qualification, validation, equipment-engineering, or related experience in 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; candidates must live within commuting distance or establish a local presence before the engagement begins.
Bachelor’s degree in engineering, life sciences, or a related technical discipline, or equivalent relevant industry experience.

Nice To Haves

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 joining an active project and becoming productive with minimal ramp-up time.

Responsibilities

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, resolutions, 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 work in accordance with approved procedures, safety requirements, cGMP expectations, and good documentation practices.
Represent Pioneer professionally, using technical credibility, sound judgment, and accountability.