Sr. CQV Specialist

Role Overview

Provide Commissioning, Qualification, and Validation (CQV) support for cGMP Clinical and Commercial Cell Therapy Manufacturing. Execute day-to-day CQV activities including protocol management, vendor management, issues/deviations, corrections, and remediation for facility/equipment/systems/processes to enable safe, compliant personalized cell therapy manufacturing and product release.

• Execute commissioning/qualification/requalification/validation and related maintenance.
• Manage multiple complex CQV projects; coordinate cross-functionally; provide status updates.
• Support/own technical & quality investigations, CAPAs, and corrections.
• Develop/perform remediation and associated CAPA plans.
• Author/own/execute master and completed CQV protocols, summary reports, and data (incl. data integrity).
• Create/revise/review change controls and SOPs; assess impact.
• Author risk assessments, FMEAs, periodic qualifications, project/master plans, annual product reviews.
• Train junior staff; present CQV work to regulators and internal audit teams.
• Decide corrective actions for deviations; determine technical approach/methodology per procedures.

• BS in Science/Engineering or equivalent.
• 7+ years relevant experience; preferred aseptic/cell therapy/testing/QA/manufacturing compliance.
• Knowledge of cGMP, FDA/EU guidance for cell-based products, and Good Tissue Practices.
• Experience with ICH and/or 21 CFR 210/211/1271 (preferred: 600/601/610).

• Medical/dental/vision; 401(k) match (vests day one).
• 8 weeks paid parental leave after 3 months.
• Paid time off (vacation/personal/sick/floating holidays) + 11 company holidays.
• Performance bonus and/or equity (eligible roles).
• Base pay: $110,706–$145,303.

• Must be authorized to work in the United States; E-Verify and Form I-9 required if selected.