Scientist III, Equipment Lifecycle Management (ELM)

Descripción

Janssen Supply Group, a member of Johnson & Johnson's family of Companies, is recruiting for a Scientist III, Equipment Lifecycle Management (ELM). This role supports both the Raritan and Titusville NJ locations, therefore routine travel between both sites is expected.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group is part of the Janssen Pharmaceutical Companies.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity! 

In this role the Scientist III, Equipment Lifecycle Management (ELM) performs the technical execution of Laboratory Services Data Analyst activities for the NJ Stability laboratory, ensuring GMP compliance, accuracy and adherence to specified project and process timelines. This position 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 Scientist III is accountable for stability lab readiness for onboarding of new lab equipment and instrumentation, applications 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. This role will act as a Subject Matter Expert (SME) in the applications used in the Laboratory Services space (Empower, Trackwise, equipment specific applications).

Key Responsibilities:

• 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.

Calificaciones

Education:

• Minimum of a Bachelor's or equivalent University Degree required

Experience and Skills:

• Minimum of 4 years of related work experience is required.

• 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)

Preferred:

• Preferred 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

Other:

• Travel is expected to be split between Raritan NJ and Titusville NJ.

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 cutting-edge 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.

• The anticipated base pay range for this position is $72,000 to $116,150

• 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. 

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 .

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.