Sr. CQV Specialist

About the Role

This position will provide Commissioning, Qualification and Validation (CQV) support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant in Raritan, NJ. The Sr. CQV Specialist will handle 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 through safe and compliant manufacturing operations according to cGMP requirements.

This role requires CQV experience, the ability to represent CQV work in regulatory and internal audits, and the capability to work independently while driving effective communication, coordination, and collaboration across cross-functional groups to establish a strong, compliant CQV program.

Responsibilities

• Executes commissioning, qualification, requalification, validation, and associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaborates with cross-functional teams, 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 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.
• Trains and supports junior team members on different CQV activities.
• Presents CQV work to regulatory and internal audit teams.
• Makes decisions on corrective action in deviation events and on technical approach/methodology per applicable procedure.
• Other responsibilities as assigned.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering, or equivalent technical discipline is required.
• A minimum of 7 years of relevant work experience, preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Experience with systems such as Microsoft suite, ERP systems (Maximo, Siemens EMS, Comet, Kneat), and testing systems (Kaye AVS, Kaye Valprobe).
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing cell-based products, as well as Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently manage a portfolio of ongoing projects.
• Highly organized, detail-oriented, and capable of working in a team environment with a positive attitude under some supervision.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 (preferred: 600, 601, and 610).
• Experience authoring and executing documentation including Batch Records, SOPs, Work Instructions, and CQV protocols.
• Fluency in English.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven company holidays.
• Voluntary benefits including flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans (pet, critical illness, accident, hospital indemnity insurance).
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay

Base pay range: $110,706 USD - $145,303 USD.

Other types of pay: Performance-based bonus and/or equity available to employees in eligible roles.