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:

Quality Control

Job Category:

Professional

All Job Posting Locations:

US004 PA Malvern - 200 Great Valley Pkwy

Job Description:

Documents critical Quality Control issues found in internal quality audits, random sample testing, intermediate quality checks, and stability testing for finished products. Applies functional knowledge of Quality Control standards to review results of quality audits and regulatory inspections, identify quality issues, and provides support corrective action plans. Conducts routine collection and dissemination of feedback to support continuous improvement of the quality management system. Tests samples of finished goods and reports defects under general supervision. Coaches more junior colleagues in techniques, processes and responsibilities.​ Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Equipment Lifecycle Management (ELM) Specialist in Malvern, PA!

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/.

The ELM Specialist is responsible for stability lab readiness for onboarding of new lab equipment and instrumentation, as well as performing the required tasks associated with this onboarding (i.e., Software Validation, Equipment Qualification, Validation, Data Integrity Risk Assessments, etc.). The ELM Specialist will reside in Malvern PA location to provide support.

Key Responsibilities:

• Lead activities such as equipment purchase, qualification, computer systems validation (CSV), troubleshooting, metrology, calibration, and maintenance
• Participate in 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 roll-outs 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
• Create change controls for new or existing equipment and initiate Quality Event Management events for equipment not meeting protocol requirements, as applicable
• Ensure compliance to Janssen Quality global and local procedures, regulatory/HA requirements, and industry standards and maintain data integrity standards for all laboratory equipment and instrumentation
• Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and CSV (e.g., GAMP 5, USP <1058>, 21 CFR Part 210/211 etc.)
• Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements
• Interact with QC Analysts to cultivate 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 degree or equivalent degree required

Experience and Skills:

Required:

• Minimum four (4) years of relevant work experience
• Experience in a Regulated Quality environment and/or Engineering Equipment Development environment
• Experience with IQ, OQ, and PQ
• Capability to creatively problem-solve and troubleshoot, develop improvement ideas, and independently implement associated solutions with minimal guidance as a proactive change agent
• Proven ability to positively influence while building and supporting strong, positive relationships with peers, partners, and management in a team environment
• Excellent written and verbal communication skills with the ability to communicate clearly and concisely with all levels

Preferred:

• Experience with equipment purchase, CSV, metrology, calibration, and/or maintenance
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
• Ability to identify/remediate gaps in processes or systems
• Experience interacting with Health Authority / Regulatory Agencies during inspections
• Experience developing content for Validation Life Cycle documents (e.g., Master Validation Plan, User Requirements, Design Specification, Test Protocols (IQ/OQ/PQ), Test Summary Reports, Data Integrity Assessments, and/or Traceability Matrix)

Other:

• Requires routine attanance in Malvern, as well as up to 10% domestic travel

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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

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Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.