Specialist, Engineering
Merck
5 months ago
On-site
Rahway, NJ
Operations
This Engineer position provides on-site engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center for sterile operations (2nd shift, Mon–Fri). Maintain facility, utilities, and manufacturing equipment per GMP and Safety using Reliability Maintenance best practices to ensure timely availability of clinical and development batches. Troubleshoot equipment and coordinate with GES, Facilities Management, OEMs, and vendors.
Provide support for Quality Engineering and capital projects, including interfacing with internal teams and external vendors to support operations, upgrades, and installation of new capital equipment. Support the equipment validation lifecycle (commissioning through decommissioning) by preparing, executing, and approving protocols; manage equipment/system changes; perform periodic reviews; evaluate deviations; issue Quality Notifications; perform investigations; identify root causes and CAPA. Maintain GMP documentation (e.g., engineering drawings and equipment database tracking). Coordinate maintenance/contractor/vendor activities, gatekeep work orders, manage purchase orders (budgets/asset depreciation), and administer capital requests/close-out. Coordinate installation, upgrades, and commissioning. Support regulatory interactions as needed.
Support sterile validation for sterilization and cleaning: act as SME; own/author/review validation SOPs, protocols, and summary reports; perform technical assessments; coordinate field execution and align equipment/instruments; resolve issues from concept to approval.
Education/Qualifications:
- Bachelor’s in engineering or science + 2+ years related Drug Product/Sterile/Validation experience.
Required skills:
- Strong familiarity with Quality, cGMP, Safety & Environmental policies; sterile drug product manufacturing equipment/process; CMMS; mechanical/electrical/automation troubleshooting; adaptability across Quality and Facility; organizational skills; communication and technical writing; strong computer skills.
Preferred skills:
- Maintenance & engineering techniques; Capital project management; independent problem-solving; SAP Plant Maintenance (gatekeeping/work order prioritization); eVal/Kneat; ProCal (CCMS); planning/scheduling and business/financial practices; ability to work independently and lead/facilitate tasks.
Application:
- Apply at https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Job posting end date: 06/15/2026; apply no later than 11:59:59 PM the day before.
Provide support for Quality Engineering and capital projects, including interfacing with internal teams and external vendors to support operations, upgrades, and installation of new capital equipment. Support the equipment validation lifecycle (commissioning through decommissioning) by preparing, executing, and approving protocols; manage equipment/system changes; perform periodic reviews; evaluate deviations; issue Quality Notifications; perform investigations; identify root causes and CAPA. Maintain GMP documentation (e.g., engineering drawings and equipment database tracking). Coordinate maintenance/contractor/vendor activities, gatekeep work orders, manage purchase orders (budgets/asset depreciation), and administer capital requests/close-out. Coordinate installation, upgrades, and commissioning. Support regulatory interactions as needed.
Support sterile validation for sterilization and cleaning: act as SME; own/author/review validation SOPs, protocols, and summary reports; perform technical assessments; coordinate field execution and align equipment/instruments; resolve issues from concept to approval.
Education/Qualifications:
- Bachelor’s in engineering or science + 2+ years related Drug Product/Sterile/Validation experience.
Required skills:
- Strong familiarity with Quality, cGMP, Safety & Environmental policies; sterile drug product manufacturing equipment/process; CMMS; mechanical/electrical/automation troubleshooting; adaptability across Quality and Facility; organizational skills; communication and technical writing; strong computer skills.
Preferred skills:
- Maintenance & engineering techniques; Capital project management; independent problem-solving; SAP Plant Maintenance (gatekeeping/work order prioritization); eVal/Kneat; ProCal (CCMS); planning/scheduling and business/financial practices; ability to work independently and lead/facilitate tasks.
Application:
- Apply at https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Job posting end date: 06/15/2026; apply no later than 11:59:59 PM the day before.