Equipment System Admin/Doc Specialist

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:

R&D Operations

Job Sub Function:

Product Development Testing

Job Category:

Business Enablement/Support

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 Equipment System Admin/Doc Specialist to join our Team! This is an onsite/hybrid role.

Manufacturing Document and System Specialist

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

As the Lentivirus Manufacturing Document and System Specialist, you will:

• Be part of the manufacturing operations team responsible for document and system management of the Lentiviral vector facility for the autologous CAR-T products in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.

• Be responsible to author, review and approve relevant LV manufacturing and equipment documents, MBR’s, SOP’s, FRM’s, TMD’s and WI’s

• Be responsible to analyze and update controlled documents for inconsistencies, gaps or errors to drive process quality improvement

• Be responsible to create equipment administration SOPs and to perform equipment data back up

• Be responsible to set up equipment retention period and to perform LV equipment audit trail review

• Be responsible for equipment lifecycle management, for equipment user access management, and other LV systems administration responsibilities.

• Support equipment qualification, maintenance and, calibration activities as needed.

• Ensure equipment preventive maintenance and calibration completed in compliance with all applicable procedures, standards and GMP regulations.

• Utilize electronic systems (Truvault, Maximo) for controlled documents and equipment management activities

• Work in an organized and safe manner and assures work area and laboratory equipment are well-organized, clean and maintained

• Conduct/document scientifically- sound, thorough, and accurate quality investigations, corrective and preventative action records in compliance with health authority requirements

• Other duties will be assigned, as necessary

• Perform system administration tasks according to standard operating procedures and record information in a clear, concise, format according to Good Documentation Practices (GDP).

• Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.

• Work in a team based, cross-functional environment to complete document and system management tasks required for the LV facility

Qualifications

• Bachelor's degree or higher required

• Other duties will be assigned, as necessary

• A minimum of two (2) years within a medical device, biological and/or pharmaceutical industry is required.

• Experience in manufacturing, maintenance, quality, testing, or engineering areas is preferred

• Proficiency with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint), Maximo, Truvault is preferred.

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is preferred.

• Candidates must be able to accommodate shift schedule. Shifts may include weekend and evening work as required by the manufacturing process.

• Proficiency in English (verbal and written), as well as, good communication skills are required

• This position will be based in Raritan, NJ

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Clinical Data Management, Communication, Execution Focus, Health Sciences, Innovation, Inventory Control, Laboratory Experiments, Laboratory Operations, Market Research, Problem Solving, Product Development, Product Strategies, Project Management, Quality Auditing, Report Writing, Research and Development, Sample Testing, Use of Laboratory Equipment

The anticipated base pay range for this position is :

$63,000.00 - $101,430.00

Additional Description for Pay Transparency:

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
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits