CQV Engineer – Cell and Gene Therapy Equipment

About the Opportunity

Pioneer GMP Consulting is seeking an experienced CQV Engineer for a client engagement supporting equipment used within a GMP-regulated cell and gene therapy manufacturing environment.

This is a hands-on execution role focused on generating, executing, and summarizing commissioning and qualification activities for manufacturing, laboratory, and supporting equipment.

The ideal candidate has approximately five to ten years of relevant CQV experience and can independently manage assigned equipment from planning and protocol development through field execution, discrepancy resolution, and final reporting.

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 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.
  

About Pioneer GMP Consulting

Pioneer GMP Consulting provides quality, compliance, validation, engineering, regulatory, technology, and operational support to pharmaceutical, biotechnology, and life sciences organizations.

Our consultants are members of the Pioneer team—not simply resources assigned to a client. They are supported by Pioneer’s leadership and network of industry experts while working directly alongside client teams to solve complex GMP challenges, strengthen quality systems, and support sustainable compliance.

We apply critical thinking, Lean GMP principles, and practical solutions to evolve traditional GMP practices. We value not only technical expertise, but also how our consultants communicate, collaborate, solve problems, build relationships, and represent Pioneer.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable federal, state, or local law.