Sr. CQV Specialist
Legend Biotech
August 24, 2026
On-site
Raritan, NJ
Operations
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.
Key Responsibilities
- 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.
Requirements
- 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).
- Author/execute CQV documentation (e.g., batch records, SOPs, work instructions, CQV protocols).
- Skills: CQV independence, strong written/oral communication, detail-oriented, process excellence tools, portfolio ownership, risk/data integrity focus.
- Systems: MS suite; ERP/validation tools (e.g., Maximo, Siemens EMS, Comet, Kneat; Kaye AVS/Valprobe). English.
Benefits (base pay + listed benefits)
- 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.
Work Authorization
- Must be authorized to work in the United States; E-Verify and Form I-9 required if selected.
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.
Key Responsibilities
- 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.
Requirements
- 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).
- Author/execute CQV documentation (e.g., batch records, SOPs, work instructions, CQV protocols).
- Skills: CQV independence, strong written/oral communication, detail-oriented, process excellence tools, portfolio ownership, risk/data integrity focus.
- Systems: MS suite; ERP/validation tools (e.g., Maximo, Siemens EMS, Comet, Kneat; Kaye AVS/Valprobe). English.
Benefits (base pay + listed benefits)
- 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.
Work Authorization
- Must be authorized to work in the United States; E-Verify and Form I-9 required if selected.