Biotech and Pharmaceutical, Change Control, Commissioning, Current Good Manufacturing Practice (cGMP), Documentation, FDA (Food and Drug Administration), FDA Requirements, IBM Maximo Asset Management, Maintain Compliance, Manufacturing, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Multitasking, Project/Program Management, Quality Assurance, Regulations, Risk Analysis, Validation Plan
Job Title: Sr. CQV Specialist
Location: Raritan, NJ
Duration: Longterm
Job Summary
Sr. CQV Specialist needed to manage and execute Commissioning, Qualification, and Validation activities in a cGMP clinical and commercial cell therapy manufacturing environment, supporting facilities, utilities, equipment, systems, and manufacturing processes.
Key Responsibilities
- Execute commissioning, qualification, requalification, and validation activities.
- Prepare, review, and execute CQV protocols, validation plans, and summary reports.
- Manage multiple CQV projects with vendors, contractors, and internal teams.
- Support deviations, CAPAs, change controls, remediation, and risk assessments.
- Ensure compliance with cGMP, GDP, FDA, EU, and applicable regulatory standards.
- Support audits and inspections by presenting CQV documentation.
- Train and guide junior team members on CQV best practices.
- Work closely with Manufacturing, QA, Engineering, Facilities, and Validation teams.
Skills Required
- 8+ years of CQV/Validation experience in pharma, biotech, medical device, or cell therapy.
- Strong knowledge of cGMP, cGTP, GDP, FDA, and EU regulations.
- Experience with equipment qualification and facility validation.
- Knowledge of change controls, deviations, CAPAs, FMEAs, and risk assessments.
- Experience with tools like Maximo, Siemens EMS, Comet, Kneat, Kaye AVS, Kaye ValProbe.
For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.