Commissioning Qualification Validation (CQV) Specialist-Raritan, NJ, On Site
- Posted: over a month ago
Position: Commissioning Qualification Validation (CQV) Specialist
Duration: 12 Months Plus
Location: Raritan, NJ, On Site
Job Function: Responsible for providing Commissioning, Qualification and Validation support a cGMP Clinical and Commercial Cell Therapy Manufacturing plant.
Scope of Job
Responsible for the day to day activities including execution, protocol management,
vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems, and processes in support of personalized cell therapy production according to cGMP requirements.
Work in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support, Supply Chain and Planning.
- Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
- Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks
- Supports and/or owns technical and quality investigations, CAPAs and corrections
- Develops and performs any required remediation efforts and associated CAPA plans
- Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity
- Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
- Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
CQV and engineering experience required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as 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.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- 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 with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
- Experience with TrackWise, CMMS and Maximo
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
Demonstrated ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.
Education & Certifications
- Bachelors in Science, Engineering or equivalent technical experience
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