What are the responsibilities and job description for the CQV Specialist I - (Contract) position at Planet Pharma?
Commissioning & Qualification (CQV) Specialist I – Contractor
Location: Somerset County, NJ (On-site)
Department: Technical Operations
Travel: Up to 5%
Position Summary
We are seeking a Commissioning & Qualification (CQV) Specialist I Contractor to support a cGMP clinical and commercial cell therapy manufacturing facility. This role will focus on the execution of core commissioning and qualification activities for controlled temperature units (CTUs), manufacturing/process equipment, laboratory/QC equipment, and supporting GMP systems.
The ideal candidate will have 2–4 years of hands-on CQV experience, specifically executing equipment and utility qualification activities in a GMP-regulated environment. Experience qualifying controlled temperature units, manufacturing/process equipment, and QC laboratory equipment is highly preferred.
This position will support protocol execution, discrepancy resolution, change management, investigations, and documentation activities while ensuring compliance with cGMP regulations and site procedures.
Key Responsibilities
Education
Location: Somerset County, NJ (On-site)
Department: Technical Operations
Travel: Up to 5%
Position Summary
We are seeking a Commissioning & Qualification (CQV) Specialist I Contractor to support a cGMP clinical and commercial cell therapy manufacturing facility. This role will focus on the execution of core commissioning and qualification activities for controlled temperature units (CTUs), manufacturing/process equipment, laboratory/QC equipment, and supporting GMP systems.
The ideal candidate will have 2–4 years of hands-on CQV experience, specifically executing equipment and utility qualification activities in a GMP-regulated environment. Experience qualifying controlled temperature units, manufacturing/process equipment, and QC laboratory equipment is highly preferred.
This position will support protocol execution, discrepancy resolution, change management, investigations, and documentation activities while ensuring compliance with cGMP regulations and site procedures.
Key Responsibilities
- Execute commissioning, qualification, requalification, and validation activities for GMP facilities, utilities, equipment, and computerized systems.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Support qualification of:
- Controlled Temperature Units (CTUs)
- Manufacturing and process equipment
- QC laboratory equipment
- Associated GMP utilities and systems
- Author, review, and execute qualification protocols and summary reports.
- Coordinate qualification activities with Engineering, Manufacturing, Facilities, Quality, and external vendors.
- Support investigations, deviations, CAPAs, corrections, and remediation activities related to validated systems.
- Participate in change control assessments and implementation activities.
- Ensure all qualification documentation complies with site procedures, cGMP requirements, and data integrity expectations.
- Assist with risk assessments, FMEAs, periodic reviews, and validation lifecycle activities.
- Maintain inspection-ready documentation supporting GMP manufacturing operations.
Education
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
- 2–4 years of hands-on Commissioning & Qualification (C&Q) experience required.
- Direct experience qualifying:
- Controlled Temperature Units (CTUs)
- Manufacturing/process equipment
- QC laboratory equipment
- Experience executing IQ/OQ/PQ protocols in a GMP-regulated environment.
- Experience supporting pharmaceutical, biotech, cell therapy, biologics, or medical device manufacturing operations preferred.
- Strong understanding of commissioning and qualification lifecycle activities.
- Working knowledge of cGMP requirements and validation principles.
- Experience with deviation management, investigations, CAPAs, and change controls.
- Ability to execute protocols independently and troubleshoot qualification issues.
- Strong technical writing skills and experience preparing qualification documentation.
- Familiarity with risk-based validation methodologies.
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Experience in cell therapy, CAR-T, biologics, or aseptic manufacturing environments.
- Knowledge of cGTP requirements.
- Experience with TrackWise, Maximo, and CMMS systems.
- Familiarity with 21 CFR Parts 210, 211, and 1271.
- Experience supporting GMP temperature mapping and CTU qualification activities.