Job Information
J&J Family of Companies Exp CRS ELM Quality Control Analyst in Malvern, Pennsylvania
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.
Qualifications
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 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.