Senior QA Validation Lead — CSV & Equipment
Initial Therapeutics, Inc.
Legend Biotech is seeking a Sr. QA Validation Specialist in Raritan, NJ, to provide quality oversight for validation and qualification activities in a cell therapy manufacturing setting. Ideal candidates must possess a Bachelor's Degree in Science and have over 7 years of experience, ideally in a GMP environment. The role necessitates strong knowledge of cGMP regulations and effective communication skills. The position offers competitive compensation and a comprehensive benefits package, including paid time off and parental leave. #J-18808-Ljbffr Initial Therapeutics, Inc.
- Legend Biotech is looking for a Sr. QA Validation Specialist, CSV & Equipment in Raritan, NJ. This role involves overseeing validation and qualification activities for systems and processes in a GMP cell therapy manufacturing plant. Ideal candidates have at least 7 years...EquipmentSenior
$127.31k - $167.1k
Legend Biotech, located in Raritan, New Jersey, is seeking a Sr. QA Validation Specialist to oversee validation activities in a cell therapy manufacturing facility. This role requires a highly organized individual with at least 7 years of relevant experience in quality...EquipmentSeniorFull time- ...Experience a must Experience in validating QMS and different modules in... ...Design Specs. Experience in QA Methodologies, designing,... ...provide quality guidance from a CSV perspective based on the Pharmaceutical... ...to work as a team player, lead a team or accomplish tasks...SeniorRemote work
$123.61k - $162.23k
Role Overview The Sr. QA Validation Specialist, CSV & Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell...EquipmentSeniorPermanent employmentFull timeContract workTemporary workWork experience placementWork at officeLocal areaFlexible hours- A leading technology consulting firm is looking for an Experienced Validation Lead to support the end-to-end validation of a Unified Regulatory Platform built on Veeva and AWS cloud technology. The ideal candidate will have over 8 years of experience in Computer System...Suggested
- ...years' experience in Computer System Validation ERP/WMS, R&D systems • A senior consultant with expert knowledge of... ...Expertise in authoring and reviewing all CSV validation deliverables. •... ...independently. • Ability to interact and lead conversations and meeting with...
$90k - $210k
We are seeking a Senior Validation Engineer with solid hands-on validation experience and a collaborative... ...activities for QC and Manufacturing equipment. In addition to many of the equipment... ...activities Knowledge of CSV methodology and required lifecycle document...EquipmentSeniorFull timeContract workFor contractorsFlexible hours- A pharmaceutical company is seeking a Quality/Validation Engineer with hands-on expertise in GxP-regulated environments and Computer System Validation (CSV). This role involves full lifecycle validation of systems like ERP and R&D platforms. The ideal candidate should have...Senior
- Creative Solutions Services, LLC in Raritan, NJ seeks a candidate experienced in Computer System Validation (CSV) within the Pharmaceutical, Biotechnology, or Medical Device industry. The role involves managing the end-to-end validation lifecycle, ensuring compliance with...Senior
- Experienced Validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud... ...Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed Providing audit...
- Overview Our client, a leading organization within the cell therapy and biopharmaceutical... ...commissioning, qualification, and validation activities within a cGMP-regulated Clinical... ...activities related to facilities, utilities, equipment, systems, and manufacturing processes...EquipmentSeniorFor contractors
- Verano is seeking a Manager of Machine Operations in Readington, NJ, to oversee machinery performance and lead a team of operators. The role involves ensuring equipment efficiency, compliance with safety standards, and direct management of two reports. Strong mechanical...EquipmentSenior
- ...Csv Specialist The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements... ...with cross-functional teams (IT, QA, business users) to ensure validation deliverables...Work experience placement
- ...: Our project managers are technical leads first, with a strong background in CQV strategy... ..., upstream and downstream biotech equipment, single use disposable, or aseptic fill... ...We provide commissioning, qualification, validation, start-up, project management and other...EquipmentSeniorFull timeWorldwide
- Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle...
$68.05k - $109.87k
...QA Investigations Lead II Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms...Work experience placementLocal areaWorldwide- ...Senior Talent Acquisition Consultant (Medical Device) The Senior Talent Acquisition Consultant (Medical Device) is responsible for... ...in tech/MedTech industries Experience with complex capital equipment and/or robotics recruiting Background in highly matrixed, large...EquipmentSenior3 days per week
- Must Have - GxP, Regulatory, Regression testing, JIRA-Xray, Functional/ manual testing, Saucelabs for multibrowser testing, data bricks, Spotfire, ISTQB/ CSTE certifications Key Responsibilities: Oversee the testing phase of projects, ensuring that software and...
- ...Mandatory - Computer System Validation, IT Compliance Management Validating Clinical systems and/or clinical supplies and/or Safety and/or Manufacturing systems, CAPA Management, Periodic Review Job Description / Key Responsibilities: • Oversee the testing phase...Work experience placement
- ...Job Title Supporting and validating regulatory systems like REMS RIMS 10+ years experience in computer system validation of regulatory systems like Regulatory Information Management System, REMS, publishing, eCTD systems used in the pharmaceutical industry. Guide...
$70.67k - $99.71k
...global biotechnology company dedicated to treating life‑threatening diseases with advanced cell therapies. Role Overview The QA Investigation Lead (II/III) is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation...Temporary workWork experience placementLocal areaFlexible hours$68.05k - $109.87k
Legend Biotech in Raritan, NJ is seeking a QA Investigations Lead I to oversee quality investigations for a sterile GMP environment. This role demands attention to detail and the ability to collaborate in a team setting. The successful candidate will work independently...- A leading biotechnology company in Raritan, NJ is seeking a QA Investigations Lead II/III to provide quality oversight during investigations of events in personalized cell therapy production. The role requires a minimum of a Bachelor's degree and 2-4 years of relevant...
- Legend Biotech is hiring a QA Investigations Lead I for their Raritan, NJ location. This exempt position focuses on providing quality oversight during investigations of events in the production of personalized cell therapy products. The role requires a Bachelor's Degree...Full time
$70.67k - $99.71k
A biotechnology company in Raritan is looking for a QA Investigation Lead to provide quality oversight in the production of personalized cell therapy products. The candidate will lead investigations, implement corrective actions, and ensure compliance with cGMP regulations...- Must Have - GxP, Regulatory, Regression testing, JIRA-Xray, Functional/manual testing, Saucelabs for multibrowser testing, Data Bricks, Spotfire, ISTQB/CSTE certifications Key Responsibilities: Oversee the testing phase of projects, ensuring that software and systems meet...
- ...Sr. BI/ETL QA Lead- 2 Roles Location - Warren NJ candidate needs to be office 3 days/week Rate - DOE BI/ETL QA Lead Strong track record of BI/ETL testing with hands-on experience of writing advanced SQL for data testing. Strong skills with advanced SQL queries...SeniorWork at office3 days per week
- ...General Qualifications And Requirements Ability to physically operate vehicle equipment and tools; must be able to lift up to 60 pounds independently Must be at least 18 years old and possess a valid driver’s license; some positions may require an MVR check Ability to work...EquipmentSeniorMonday to Friday
$90k - $250k
...We are seeking a highly motivated Senior Director, Supply Chain reporting to our VP of Operations who will lead and oversee the buildout of our Supply Chain organization... ...and critical raw materials, components, equipment, and maintenance supplies. This is a multidisciplinary...EquipmentSeniorLocal areaFlexible hoursShift work$68.05k - $109.87k
Legend Biotech in Raritan, NJ is looking for a QA Investigations Lead I to provide quality oversight during the investigation of events in the production of cell therapy products. Responsibilities include ensuring timely and accurate investigations, supporting regulatory...
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