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Equipment Management Specialist - 2406198781W

Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Equipment Management Specialist in Raritan, NJ!

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/.

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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity!

The EM Specialist is responsible for equipment lifecycle management and Quality Control (QC) systems administration. They work independently on routine tasks and will demonstrate a conceptual understanding of all Quality Control functions and business areas.

Key Responsibilities :

• Lead activities such as equipment purchase, qualification, computer systems validation (CSV), troubleshooting, metrology, calibration, and maintenance

• Support the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications

• Maintain lab equipment in a validated state following established GxP regulations

• Support system upgrades, maintenance, and rollouts of new systems, as needed and review/approve CSV documents including reviewing of Change Requests

• Collaborate with Global Quality Systems, IT, and site facilities to support ongoing instrument and applications troubleshooting, maintenance, retirement, and change management, with preferred knowledge with the LIMS system

• Create change controls for new or existing equipment and initiate Quality Event Management events for equipment not meeting protocol requirements, as applicable

• Interact with QC Analysts to nurture open dialogue regarding equipment metrology, maintenance, calibration, and repairs

• Negotiate/set-up vendor contracts/Purchase Orders (PO), ensuring all GMP vendors are listed on Approved Service Provider and 3rd Party Service Provider list and all assessments are performed and reviewed

Qualifications

Education:

• Minimum of Bachelor's or equivalent University degree required in Sciences or Engineering

Experience and Skills:

Required:

• Minimum two (2) years of relevant work experience

• Familiarity with QC equipment, equipment purchase, qualification, computer systems validation (CSV), troubleshooting, metrology, calibration, and maintenance

• Experience in a Regulated Quality environment, Quality Control, and/or Engineering Equipment Development environment

• Excellent written and verbal communication skills with the ability to communicate clearly and concisely with all levels

• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory

Preferred but not Required:

• Experience negotiating, setting up vendor contracts, purchase orders and ensuring GMPS vendors are listed on Approved Service Provider and 3rd Party Service Provider list

• Experience interacting with Health Authority / Regulatory Agencies during inspections

Other:

• Requires up to 10% domestic travel

• The anticipated base pay range for this position is 76000 to 121900.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

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

• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

#CAR-T

Primary Location NA-US-New Jersey-Raritan

Organization Janssen Pharmaceuticals, Inc. (6062)

Travel Yes, 10 % of the Time

Job Function Quality Control

Req ID: 2406198781W