Sr. CSV Specialist
Legend Biotech
August 12, 2026
On-site
Raritan, NJ
IT
Role Overview:
Provide Commissioning, Qualification, and Validation (CSV/QV) support to computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. Execute day-to-day CSV activities including protocol management, vendor management, issue/deviation handling, corrections, and remediation for facility, equipment, systems, and processes to support safe, compliant personalized cell therapy production.
Key Responsibilities:
- Act as SME for 21 CFR Parts 210, 211, 11 and EU Annex 11.
- Implement and maintain CSV tools, standards, policies, and procedures.
- Execute commissioning/qualification/requalification/validation for computerized systems (e.g., SAP, MES, BAS, EDS; manufacturing/lab and facility/utility systems).
- Manage multiple complex CSV/CQV projects; provide status updates; coordinate with departments and vendors.
- Support/own technical and quality investigations, CAPAs, and corrections; develop remediation and CAPA plans.
- Author/own/execute master and completed CSV/CQV protocols and summary reports; ensure data integrity.
- Create/revise/review change controls and SOPs/documentation.
- Author risk assessments (e.g., FMEAs), periodic qualifications, project/master plans, and annual product reviews.
Requirements:
- BS in Science/Engineering or equivalent.
- 8+ years relevant experience with 21 CFR 11, 58, 210, 211; Eudralex and ICH.
- GMP compliance expertise; working knowledge of GMP data integrity.
- Knowledge of cGMP and FDA/EU guidance for cell products; Good Tissue Practices.
- ICH and/or 21 CFR 210/211/1271; 600/601/610 preferred.
- Strong written/oral communication; ability to make critical decisions with limited info.
- Proficient with documentation (batch records, SOPs, work instructions, protocols); TrackWise, CMMS, Maximo; Microsoft Office.
- Detailed cGMP/cGTP knowledge for CAR-T/cell processing; ability to identify/remediate gaps.
- Prefer experience in aseptic cell therapy/testing/QA/manufacturing compliance.
Benefits and Paid Time Off (per job posting):
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays) and 11 company holidays; voluntary benefits including flexible spending/HSAs, life/AD&D, short/long-term disability, legal assistance, and supplemental insurance.
- Base pay range: $110,706–$145,303.
Application/Employment Eligibility:
- Applicants must be authorized to work in the U.S.; employment eligibility verified via E-Verify; selected candidates complete Form I-9.
Provide Commissioning, Qualification, and Validation (CSV/QV) support to computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. Execute day-to-day CSV activities including protocol management, vendor management, issue/deviation handling, corrections, and remediation for facility, equipment, systems, and processes to support safe, compliant personalized cell therapy production.
Key Responsibilities:
- Act as SME for 21 CFR Parts 210, 211, 11 and EU Annex 11.
- Implement and maintain CSV tools, standards, policies, and procedures.
- Execute commissioning/qualification/requalification/validation for computerized systems (e.g., SAP, MES, BAS, EDS; manufacturing/lab and facility/utility systems).
- Manage multiple complex CSV/CQV projects; provide status updates; coordinate with departments and vendors.
- Support/own technical and quality investigations, CAPAs, and corrections; develop remediation and CAPA plans.
- Author/own/execute master and completed CSV/CQV protocols and summary reports; ensure data integrity.
- Create/revise/review change controls and SOPs/documentation.
- Author risk assessments (e.g., FMEAs), periodic qualifications, project/master plans, and annual product reviews.
Requirements:
- BS in Science/Engineering or equivalent.
- 8+ years relevant experience with 21 CFR 11, 58, 210, 211; Eudralex and ICH.
- GMP compliance expertise; working knowledge of GMP data integrity.
- Knowledge of cGMP and FDA/EU guidance for cell products; Good Tissue Practices.
- ICH and/or 21 CFR 210/211/1271; 600/601/610 preferred.
- Strong written/oral communication; ability to make critical decisions with limited info.
- Proficient with documentation (batch records, SOPs, work instructions, protocols); TrackWise, CMMS, Maximo; Microsoft Office.
- Detailed cGMP/cGTP knowledge for CAR-T/cell processing; ability to identify/remediate gaps.
- Prefer experience in aseptic cell therapy/testing/QA/manufacturing compliance.
Benefits and Paid Time Off (per job posting):
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays) and 11 company holidays; voluntary benefits including flexible spending/HSAs, life/AD&D, short/long-term disability, legal assistance, and supplemental insurance.
- Base pay range: $110,706–$145,303.
Application/Employment Eligibility:
- Applicants must be authorized to work in the U.S.; employment eligibility verified via E-Verify; selected candidates complete Form I-9.