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 https://www.jnj.com

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

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

Summary:

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.

Key Responsibilities:

• 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.

Qualifications:

Education:

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

Experience and Skills:

Required:

• 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 within Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry

Preferred:

• 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

Other:

• 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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility

 

 

The anticipated base pay range for this position is :

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year