BioSpace
Legend Biotech
is a global biotechnology company working to treat life‑threatening diseases with advanced cell therapies.
Position CQV Specialist I
– Technical Operations, Raritan, NJ.
Role Overview Responsible for providing Commissioning, Qualification, and Validation (CQV) support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. Handles day‑to‑day activities including protocol management, vendor management, deviation resolution, and remediation to support safe, compliant manufacturing operations.
Key Responsibilities
Execute commissioning, qualification, requalification, validation, and associated maintenance activities.
Manage multiple CQV projects, coordinate with vendors, and provide status reports.
Support technical and quality investigations, CAPAs, and corrections.
Develop remediation efforts and CAPA plans.
Author and own CQV protocols, summary reports, data, and ensure data integrity.
Participate in creation and review of change controls, SOPs, and documentation.
Contribute to risk assessments, FMEAs, periodic qualifications, project plans, and product reviews.
Collaborate with Quality, Manufacturing Operations, Facilities, Engineering, QC, Supply Chain, and Planning.
Requirements
Bachelor’s Degree in Science, Engineering or equivalent.
Minimum 2 years relevant experience; experience in aseptic manufacturing, cell therapy, or quality assurance is preferred.
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Strong interpersonal, written and oral communication skills.
Ability to process complex information and make critical decisions.
Process excellence tools and methodologies proficiency.
Experience with ICH/21 CFR guidance, documentation (batch records, SOPs, CQV protocols).
Familiarity with tools such as TrackWise, Comet, CMMS, Veeva, Maximo, Microsoft Office.
English language proficiency.
Compensation Base pay range: $81,273 – $106,669 USD.
Benefits Medical, dental and vision insurance; 401(k) with company match; equity and stock options; 8 weeks paid parental leave; paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 3 floating holidays); flexible spending & health savings accounts; life and AD&D insurance; disability coverage; legal assistance; supplemental plans; commuter benefits; family planning resources; well‑being initiatives; peer‑to‑peer recognition.
EEO Statement Legend Biotech is an equal‑opportunity employer committed to a diverse workforce. Employment is at‑will and terms may change. Legend maintains a drug‑free workplace.
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is a global biotechnology company working to treat life‑threatening diseases with advanced cell therapies.
Position CQV Specialist I
– Technical Operations, Raritan, NJ.
Role Overview Responsible for providing Commissioning, Qualification, and Validation (CQV) support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. Handles day‑to‑day activities including protocol management, vendor management, deviation resolution, and remediation to support safe, compliant manufacturing operations.
Key Responsibilities
Execute commissioning, qualification, requalification, validation, and associated maintenance activities.
Manage multiple CQV projects, coordinate with vendors, and provide status reports.
Support technical and quality investigations, CAPAs, and corrections.
Develop remediation efforts and CAPA plans.
Author and own CQV protocols, summary reports, data, and ensure data integrity.
Participate in creation and review of change controls, SOPs, and documentation.
Contribute to risk assessments, FMEAs, periodic qualifications, project plans, and product reviews.
Collaborate with Quality, Manufacturing Operations, Facilities, Engineering, QC, Supply Chain, and Planning.
Requirements
Bachelor’s Degree in Science, Engineering or equivalent.
Minimum 2 years relevant experience; experience in aseptic manufacturing, cell therapy, or quality assurance is preferred.
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Strong interpersonal, written and oral communication skills.
Ability to process complex information and make critical decisions.
Process excellence tools and methodologies proficiency.
Experience with ICH/21 CFR guidance, documentation (batch records, SOPs, CQV protocols).
Familiarity with tools such as TrackWise, Comet, CMMS, Veeva, Maximo, Microsoft Office.
English language proficiency.
Compensation Base pay range: $81,273 – $106,669 USD.
Benefits Medical, dental and vision insurance; 401(k) with company match; equity and stock options; 8 weeks paid parental leave; paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 3 floating holidays); flexible spending & health savings accounts; life and AD&D insurance; disability coverage; legal assistance; supplemental plans; commuter benefits; family planning resources; well‑being initiatives; peer‑to‑peer recognition.
EEO Statement Legend Biotech is an equal‑opportunity employer committed to a diverse workforce. Employment is at‑will and terms may change. Legend maintains a drug‑free workplace.
#J-18808-Ljbffr