QA Validation Specialist II LVV

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for QA Validation Specialist II LVV! .This position will be located in Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming 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. is part of the Janssen Pharmaceutical Companies.

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 designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

In this role, you will be providing quality oversight for daily activities related to the production of analytical cell banks, cryopreservation of human apheresis and testing of viral vectors in a controlled cGMP environment. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

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 exciting opportunity!

Main Responsibilities will include, but are not limited to:

• Applies Quality Assurance knowledge of guidelines and surfaces issues that may impact organizational objectives.
• Environmental Monitoring Data
  Review and ensure compliance of viable and non‑viable particulate monitoring, airflow, differential pressure, humidity, and temperature data needed for cleanroom release.
• Verify Compliance with GMP and ISO Cleanroom Standards
  Assess cleanroom performance against ISO 14644 and GMP Annex 1 requirements, including cleanliness levels "at rest" and "in operation when needed.
• Evaluate Contamination Control and HVAC Performance
  Monitor and review contamination control measures, including HVAC performance, surface cleanliness, and particulate control, to ensure clean-rooms maintain required class standards when required.
• Document Validation Activities and Maintain Cleanroom Validation Records
  Maintain detailed validation protocols, results, deviations, corrective actions, and environmental monitoring logs as required for regulatory compliance and audit readiness.
• Support Investigations
• Oversee Equipment/Facility/Process Qualification (URS/Config Specs/QRA/IQ/ OQ/PQ/AVS/EMPQ/APS)
  Perform or review equipment qualification—including installation, operational, and performance qualification—ensuring systems perform consistently for intended use.
• Oversee Computerized System Validation (CSV)
  Must ensure that the selection, validation, maintenance and retirement of computerized systems that are handled in a consistent manner following a standardized process. Provide CSV support of Process of planning, Installation, Validation, Upgrades/modifications, operation, maintenance, and retirement of the computerized system used as part of the GxP regulated using the manufacturing area from Concept Phase through to the Retirement Phase. Be familiarized with AIQ and RBA deliverables, such as GAMP categories, and AIQ, Annex 11, Part 11, Data Integrity, EHS&S, System Impact assessments and Traceability/Test Matrix.
• Review Calibration and Preventive Maintenance Status and Confirm GMP Compliance of Equipment Documentation
  Verify that all equipment has current calibration, maintenance, and is functioning within validated parameters prior to approving release.

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