eLIMS Site Key User

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:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting an eLIMS Site Key User located in Titusville, NJ.

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

The eLIMS Site Key User is responsible for leading and providing oversight for all eLIMS activities for Janssen Supply Chain - Stability Laboratories to ensure operations remain aligned with corporate and local requirements.

This role provides system expertise by understanding the E2E laboratory business processes including sampling, sample distribution, laboratory planning, analytical testing, data reporting, and trending analysis. They are responsible for determining the business impact to all eLIMS changes, events, or upgrades, and partnering with the eLIMS Quality Application Owner to detail, plan, and implement impact assessments based on the identified changes.

This role is responsible for communicating, aligning, and providing training to employees on all relevant eLIMS changes. Support may include understanding and assessing site requirements to translate these into a business benefit. This role will be the point of contact for site inspections related to eLIMS events and will provide support to laboratory and site eLIMS users.

Key Responsibilities:

• Provide end-user support and system management administration for the Laboratories directly related to eLIMS and associated systems such as Empower and other computer applications
• Perform eLIMS computer system validation (CSV) activities associated with new system interface and new instrument introductions
• Ensure accuracy, completeness, and cGMP compliance with associated documentation as it pertains to eLIMS and applicable systems
• Collaborate with Global Quality Systems, eLIMS Master Data Management, and IT to support ongoing system and applications troubleshooting, maintenance, retirement, and change management efforts in a timely manner
• Ensure the system is used to its full potential, remaining up to date on all changes and enhancements of the system, translating this to site practices, and leading change where needed
• Define site impact for eLIMS intakes and aligns with site and laboratory leaders on initiatives from user forum meetings
• Ensure compliance to J&J IM Quality global and local procedures, regulatory/ Health Authority requirements, and industry standards
• Develop and maintain site procedures and ensure their alignment to global SOPs and site training material
• Train new site users and performing recurrent training as needed
• Manage site quality events as eLIMS SME where there is a potential for product impact
• Support internal audits and Health Authority inspections and engage with inspectors as a site eLIMS SME
• Maintain expertise with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and computer systems validation (e.g., GAMP 5, USP <1058>, 21 CFR Part 210/211 etc.)

Qualifications:

Education:

• Minimum of a Bachelor's or equivalent University degree required; focused degree in Science, Engineering, IT, or related technical field preferred

Experience and Skills:

Required:

• Minimum 6 years of relevant work experience
• Experience with LIMS, eLIMS, and/or iLABs applications
• Strong interpersonal and written/oral communication skills
• Technical knowledge and understanding of CSV and appl