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
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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.
Qualifications
Education:
- A minimum of a bachelor's degree in Engineering, Science or equivalent technical field is required.
Experience and Skills:
Required:
- A minimum of (2) years of experience in Quality Assurance related to manufacturing is required with a preference for 4 years experience.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products.
- Knowledge of Good Tissue Practices.
- Ability to pay attention to details and follow the procedures.
- Strong ability to prioritize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with other team members that may impact timely completion. Ability to effectively handle multiple tasks and activities simultaneously.
- Ability to summarize and present results, and experience with team-based collaborations.
- Experience maintaining written records of work in the form of notebooks, technical reports and protocols.
Preferred:
- Experience in clinical quality, method development, cell banking, or Research & Development.
- Substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and other applicable standards.
- Ability to interact effectively with manufacturing, automation/IT, laboratory, QA, and Facilities groups.
- Experience working with cell therapy.
Other:
- Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
- This position is located in Raritan, NJ and may require up to 5% of domestic travel.
- This position has an estimated annual salary range of 60,000- 108,000 USD$
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]