Sr Engineer, Manufacturing Systems

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

This role is for a Sr. Engineer in Manufacturing Systems at Johnson & Johnson, focusing on implementing and supporting Siemens Opcenter MES. Responsibilities include troubleshooting, process mapping, change control, system design/configuration, testing, validation, and continuous improvement using production data. The role requires experience in medical device manufacturing, QMS, and compliance with regulations like FDA 21 CFR Part 11.

What you'd actually do

  1. Provide onsite support for Opcenter-enabled production operations; troubleshoot issues, restore service quickly, and coordinate escalations with IT and vendors as needed
  2. Lead and coordinate cross-functional workshops to define requirements, map current/future state processes, and align implementation plans and validation strategy
  3. 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
  4. 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
  5. 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

Skills

Required

  • 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 21 CFR Part 11, GDP/GMP) including data integrity and audit readiness
  • Strong problem-solving and root-cause analysis skills
  • Excellent communication and stakeholder management skills

Nice to have

  • comfortable working under time pressure in a production environment
  • able to lead discussions, influence decisions, and drive execution across functions
  • occasional off-hours/weekend support may be required during cutovers, go-lives, or critical production events

What the JD emphasized

  • QMS
  • validated state
  • computer system validation
  • data integrity
  • FDA 21 CFR Part 11
  • audit readiness