Sr Engineer, Manufacturing Systems

Sr Engineer, Manufacturing Systems – responsible for supporting and enhancing Opcenter MES operations across production and quality functions.

• Provide onsite support for Opcenter-enabled production operations; troubleshoot issues, restore service quickly, and coordinate escalations with IT and vendors as needed.
• Lead and coordinate cross‑functional workshops to define requirements, map current/future state processes, and align implementation plans and validation strategy.
• Own change control for manufacturing system and process changes in alignment with the Quality Management System (QMS): impact assessment, risk evaluation, documentation, testing, approvals, deployment, and communication to maintain a validated state.
• Design, configure, and improve Opcenter MES capabilities (e.g., routings/operations, electronic work instructions, data collection, equipment/line modeling, genealogy/traceability, electronic records) to support production execution and Device History Record/electronic batch record needs, including UDI‑related data where applicable.
• Plan and execute testing (unit/integration/UAT) and support computer system validation activities (e.g., URS/FRS, traceability, IQ/OQ/PQ, Part
  11 assessment) and data integrity controls in partnership with Quality and IT.
• Drive continuous improvement by analyzing production and quality data (e.g., yield, scrap, nonconformances) to identify defects, bottlenecks, and opportunities for standardization and error‑proofing within Opcenter workflows.
• Develop and maintain controlled SOPs/work instructions, training materials, and a sustainable support model (key‑user network, knowledge base, release playbooks, metrics) for shop‑floor and support teams.

• B.S. degree in Engineering, Computer Science, Information Systems, or equivalent.
• 7+ years of experience in manufacturing systems, automation/IT for manufacturing, or process engineering with strong exposure to shop‑floor operations.
• Hands‑on experience implementing and supporting Siemens Opcenter (or comparable MES) and integrating MES with ERP and shop‑floor systems (e.g., SAP, equipment interfaces, label/UDI systems).
• Experience in medical device manufacturing and familiarity with QMS and compliance expectations (e.g., ISO
  13485, FDA
  21CF
  RPart
  11, GDP/GMP) including data integrity and audit readiness.
• Strong problem‑solving and root‑cause analysis skills; comfortable working under time pressure in a production environment.
• Excellent communication and stakeholder management skills; able to lead discussions, influence decisions, and drive execution across functions.

Pay range: $94,000.00 – $ per year (eligible for an annual performance bonus). Benefit programs include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Eligible for a consolidated retirement plan (pension) and savings plan (401k). Eligible for a long‑term incentive program. Time‑off benefits: vacation up to 120hours per calendar year; sick time up to 40hours (up to 56hours for employees in Washington);

holiday pay, including floating holidays up to 13days; work, personal, and family time up to 40hours.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section
503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via  or contact AskGS to be directed to your accommodation resource.