ELM Specialist

Johnson Supply Group, LLC., part of the Johnson & Johnson Family of companies, is currently recruiting for an ELM Specialist position. This position will be based out of Raritan and Titusville, New Jersey.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.

With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

The J&J Supply Chain is an integrated, global supply chain that serves the needs of the 1 billion people who use J&J products each and every day around the world. We manufacture more than 26 billion product units per year, from raw component sourcing to end product distribution as efficiently and effectively as possible with high quality, compliance, and service performance. Our supply chain organization makes up 45% of all J&J employees, and includes 125 internal manufacturing plants, manages 581 external manufacturers, utilizes 459 distribution centers, partners with over 3700 direct suppliers, produces over 300,000 sku’s.

The Equipment Lifecycle Management (ELM) Specialist performs the technical execution of ELM Quality Control activities for the NJ Stability laboratory, ensuring GMP compliance, accuracy, and adherence to specified project and process timelines. The ELM Specialist carries out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, DEA, OSHA, etc.) as well as all company and site policies and procedures.

The ELM Specialist is accountable for stability lab readiness for onboarding of new lab equipment and instrumentation and performance of the required tasks associated with this onboarding (i.e., Software Validation, Equipment Qualification, Validation, Data Integrity Risk Assessments, etc.). They will act as the first point of contact for issues that arise in the areas of ELM and Lab Systems space.

The ELM Specialist is accountable to manage and assure quality & compliance for lab equipment and instrumentation and ensure all regulatory commitments are met. They will act as a lab SME for issues that arise in the area of ELM. This role supports both the Raritan and Titusville NJ locations, therefore routine travel between both sites is expected.

Duties & Responsibilities

General:

• Maintain data integrity standards for all lab equipment and instrumentation
• Support system upgrades, maintenance, and roll-outs of new systems, as needed
• Ensure accuracy, completeness, and cGMP compliance in laboratory documentation as it pertains to Equipment Lifecycle Management
• Maintain and schedule Preventative Maintenance, Calibration and Service Calls
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Uphold our Credo values including creating a positive work environment

ELM Support:

• Use Maximo software to maintain and schedule preventative / corrective maintenance, calibration and service calls.
• Interact with QC analysts to foster open dialogue regarding equipment metrology, maintenance, calibration, and repairs
• Responsible for providing analytical support on data review of equipment qualification including Installation Qualification, Operational Qualification, Performance Qualification, Preventative Maintenance, and calibration documents
• Lead activities such as equipment purchase, qualification, software validation, troubleshooting, metrology, calibration, and maintenance
• Responsible for creation of change controls for new or existing equipment and initiation of Quality Event Management events for equipment not meeting protocol requirements, as applicable
• Develop content for Validation Life Cycle documents like Master Validation Plan, User Requirements, Design Specification, Test Protocols (IQ/OQ/PQ), Test Summary Reports, Data Integrity Assessments, Traceability Matrix, Compliance Reports and Release Notifications for computerized systems
• Participate in the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications
• Negotiates/set-ups vendor contracts/Purchase Orders (PO). Responsible for ensuring that all GMP vendors are listed on Approved Service Provider and 3rd Party Service Provider list and all assessments are performed and reviewed
• Collaborates with site facilities (facilities) for lab building requirements (e.g., water, Compressed gases, electrical) and lab improvement projects.

Projects / Meetings:

• Assess talent by participating in panel interviews for QC job candidates
• Provide input to / lead functional laboratory meetings
• Interface with Global Quality Systems and IT, as needed
• Provide input and take actions as a QC Technical representative at cross-functional meetings
• Engage with Global Equipment Lifecycle Management CoE and ELM peers at other sites to leverage practices across the JSC Lab Network
• Support the development and execution of CREDO and Lean Lab action plans and initiatives

Quality & Compliance

• Support internal audits and Health Authority inspections as a local SME
• Ensure compliance to JSC Quality global and local procedures, regulatory/ Health Authority requirements, and industry standards
• Complete and approve corrective and preventative actions (CAPA) as assigned
• Maintain high level of familiarity 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.).
• Maintain lab computer systems in a validated state following established GxP regulations.
• Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements
• Other duties as assigned by management

Qualifications

Required:

• Bachelor’s Degree
• Ability to work with others in a team environment
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
• Technical knowledge and understanding of computer system validation and application support
• Experience with troubleshooting / root cause analysis techniques for equipment and software related issues in a QC laboratory or related environment
• Understanding of equipment and instrument qualification, preventative maintenance, and calibration
• Strong interpersonal and written/oral communication skills
• Ability to quickly process complex information and often make critical decisions with limited information
• Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities
• Ability to independently manage a portfolio of ongoing projects
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
• Advanced with using Microsoft Office applications (Outlook, Excel, Word, Project and PowerPoint)
• Travel is expected to be split between Raritan NJ and Titusville NJ.

Preferred:

• Bachelor’s Degree in Science, Engineering, IT, or related field
• Experience in a regulated quality environment, IT, and/or engineering equipment development environment
• Creativity regarding basic problem solving and troubleshooting
• The QC ELM Specialist shall have the capability to develop improvement ideas and independently implement associated solutions
• Possesses the ability to positively influence peers, key stakeholders, and management
• Positive and optimistic with the ability to act as a pro-active change agent

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.

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.