Job Title: CQV Specialist (Contract)
Location: Raritan, NJ
Strictly no C2C
Position Overview: This role requires a strong background in CQV and engineering, with the ability to work independently and collaborate effectively with cross-functional teams to maintain a robust, compliant CQV program, ensuring the safe and efficient production, testing, and release of personalized cell therapy products.
Key Responsibilities:
- Execute commissioning, qualification, requalification, validation, and maintenance activities within the manufacturing plant.
- Manage multiple complex CQV projects, providing regular status reports and coordinating with internal departments and external vendors.
- Lead or support technical and quality investigations, Corrective and Preventive Actions (CAPAs), and remediation efforts.
- Develop and execute remediation plans and associated CAPA strategies.
- Author, own, and execute CQV protocols, summary reports, and data analyses to ensure compliance with regulations, SOPs, and specifications, with a focus on data integrity.
- Create, revise, and review change controls, SOPs, and other documentation as required.
- Participate in the development of Risk Assessments, Failure Modes and Effects Analyses (FMEAs), Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
Requirements:
- Bachelor’s degree in Science, Engineering, or a related technical discipline.
- Minimum of 2 years of relevant experience, preferably in an aseptic manufacturing environment such as cell therapy, testing facility, quality assurance, or manufacturing compliance.
- Strong understanding of cGMP regulations and FDA/EU guidance on cell-based product manufacturing, along with Good Tissue Practices.
- Excellent interpersonal and communication skills, both written and verbal.
- Ability to process complex information quickly and make critical decisions with limited data.
- Proficiency in process excellence tools and methodologies.
- Strong attention to detail and adherence to established procedures.
- Highly organized and capable of working collaboratively in a team environment with minimal supervision.
- Experience with team-based collaboration and ability to summarize and present results effectively.
- In-depth knowledge of current Good Manufacturing Practices (cGMP) and Good Tissue Practices (GTP) specific to CAR-T manufacturing or cell processing.
- Ability to identify and address gaps in processes or systems.
- Experience with ICH guidelines and/or 21 CFR parts 210, 211, 1271, and preferably 600, 601, and 610.
- Proven experience in authoring and executing documentation, including Batch Records, SOPs, Work Instructions, and CQV protocols.
- Familiarity with TrackWise, CMMS, and Maximo systems.
- Proficiency in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).