Quality Assurance Equipment/Computer System Validation Specialist II

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing. This position will be located in Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is crafted to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this great opportunity!

The QA Equipment/CSV Specialist II is responsible for providing quality oversight over a wide range of Equipment and Computer System Validation (CSV) activities for qualification/validation projects in the Raritan CAR-T facility to support clinical and commercial efforts.

Key Responsibilities:

• Provide QA oversight and compliance review of validation protocols and final reports during the qualification / validation process on various equipment/instruments, facility and IT systems.

• Support successfully transfer process to cGMP facility to manufacture products.

• Support in evaluating all the tests to qualify critical equipment, utilities and processes.

• Review open deviations and investigations relating to qualification / validation issues and help to resolve complex challenges.

• Works with IT partners to ensure configuration and documentation of computerized systems to meet the requirements of CFR21 Part 11.

• Review project and validation documentation for the site's QMS (Document Management/Compliance Modules) and validation projects to ensure compliance.

• Review and oversee execution FAT, SAT and Commissioning of Equipment.

• Review and suggest continuous improvements to the validation master plan, current quality system practices, validation protocols and procedures for newly installed equipment and overall validation strategies.

• Perform compliance review of all Deviations, Investigations and CAPAs related to qualification and validation activities and ensure effectiveness of related actions.

• Assess, Review, and approve change controls related to manufacturing, laboratory and facility systems.

• Strive to reduce non-conformances in supported areas by proactively driving compliance.

• Perform tasks in a timely manner consistent with the safety policies, quality systems and cGMP requirements.

• Other duties will be assigned, as necessary.