Lenti Investigator

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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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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.

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 a Lenti Investigator to join our team in Raritan, NJ.

The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances.

• Conduct root cause analysis investigations and author nonconformance reports.
• Coordinate discussion to identify process improvements related to safety, environmental, quality, compliance, efficiency, and yield.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.
• 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 in support of nonconformance management and/or audit activities

• 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 technical documents,SOPs, common scientific / technical journals, legal documents, and government regulations/guidance documents (EU GMPs, Annex 1, CFR, USP)
• Excellent written and oral communication skills
• Experience with in cell/gene therapy, biopharmaceutical, or pharmaceutical industry

• Experience with one or more of the following enterprise systems: eLIMS, Salesforce, Maximo, EMS, Track Wise, Veeva, and/or SAP
• Experience with internal and/or external regulatory audits/inspections
• Experience with quality investigations, including root-cause analysis of nonconformance events and familiarity with root cause analysis tools

• 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 like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.

$65,000.00 - $

Subject to the terms of…