Sr. CSV/CQV Specialist
$110,706–$145,303 year
On-siteRaritan, New Jersey, United States
EXPIREDRaritan, New Jersey, United StatesOn-siteFull Time$110,706–$145,303 yearSenior LevelBiotechnologyLarge
Full TimeSenior LevelLargeBiotechnology
Job Summary
Execute commissioning, qualification, requalification, and validation activities for all computerized systems, including SAP, MES, and laboratory equipment, within the cGMP plant. Manage complex CSV and CQV projects, oversee vendor coordination, and lead technical investigations, CAPAs, and remediation efforts. Author and own master protocols, summary reports, and change controls while ensuring strict adherence to 21 CFR Parts 210, 211, and EU Annex 11. This role supports personalized cell therapy production through a robust, compliant CSV and CQV program.
Required Qualifications
- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline
- A minimum of 8+ years relevant work experience
- expertise in 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines
- Experience working in an aseptic manufacturing facility
- preferably cell therapy, testing facility, quality assurance, or manufacturing compliance
- Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among others
- Experience with ICH and/or 21 CFR parts 210, 211, 1271
- 600, 601, and 610
- Thorough knowledge and understanding of GMP data integrity standards
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products
- knowledge of Good Tissue Practices
- Strong interpersonal and written/oral communication skills
- Ability to quickly process complex information and often make critical decisions with limited information
- Proficient in applying process excellence tools and methodologies
- Ability to independently be responsible for a portfolio of ongoing projects
- Ability to pay attention to details and follow the procedures
- highly organized and capable of working in a team environment with a positive attitude under some supervision
- Good written and verbal communication skills
- Ability to summarize and present results
- experience with team-based collaborations
- Ability to work with others in a team environment
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing
- Ability to identify/remediate gaps in processes or systems
- Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, protocols
- Experience with TrackWise, CMMS and Maximo
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Desired Qualifications
- It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance
- 600, 601, and 610
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