Investigator - Lentiviral Vector

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 Med Tech, 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.

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Supply Chain Manufacturing

Manufacturing Pharmaceutical Process Operations

Professional

Raritan, New Jersey, United States of America

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for an Investigator - Lentiviral Vector to join our Team in Raritan, NJ.

The Investigator will be the primary technical expert to help identify true root cause of investigations and assess product quality impact. This individual will perform investigation and identify resolution for deviations and atypical events. They will recommend, own, and implement corrective/preventative measures sought at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.

• Establish corrective actions adequately addressed root cause of nonconformance event.
• Track deviations, events and key process parameters and provides reports to management on trending, and status as requested.
• Identify and implement process improvements related to safety, environmental, quality, compliance, efficiency, yield, and cost.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.
• Assure regulatory compliance and technical feasibility of proposed changes.
• Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs.

• A minimum of a Bachelor’s degree is required, focus degree in Engineering and/or Life Science is preferred.

• Minimum 2 years of relevant work experience
• Ability to read, analyze, and interpret procedure manuals, common scientific / technical journals, basic financial reports and legal documents, general business periodicals, and government regulations
• Excellent written and oral communication skills to respond to critical inquiries or complaints from top managers, regulatory agencies, or members of the business community
• Experience with in Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry

• Experience with one or more of the following enterprise systems: eLIMS, Comet Salesforce, Maximo, EMS, BMS, and/or SAP
• Experience with internal and/or external regulatory audits
• Experience with quality investigations, including root-cause analysis of nonconformance events
• Demonstrated ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations

• May require up to 10% domestic travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would…