Sterile Operations Engineer & Validation SME

Merck & Co.; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck & Co. in Rahway, NJ seeks an on-site Engineering position to support the FLEx Sterile manufacturing area. The role collaborates with Operations, Quality, Engineering, and Maintenance to ensure reliable, compliant sterile production.

Primary focus on Sterile 2, with readiness for Sterile 1 as needed. The incumbent provides QA/QE support across equipment reliability, validation, and lifecycle management, while coordinating with GES, FM/GWES, OEMs and vendors.

Qualifications

• Bachelors degree in engineering or science with 2+ years of related Drug Product/Sterile/Validation experience.
• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Sterile Drug Product manufacturing equipment and process.
• Familiarity with CMMS / maintenance systems.
• Troubleshooting ability across mechanical, electrical and automation domains.
• Ability to adapt across Quality and Facility to support the business.
• Strong organizational skills and technical writing ability.
• Proficient computer skills

Responsibilities

• Support the full equipment lifecycle from commissioning through decommissioning.
• Author, execute, review and approve qualification and validation documentation.
• Manage equipment and system changes; conduct periodic reviews.
• Support investigations, deviations, QNs and CAPAs.
• Maintain GMP engineering documentation and asset records.

Skills

Quality & cGMP

Sterile manufacturing

CMMS

Troubleshooting (M/E/A)

Cross-functional collaboration

Technical writing

Strong computer skills

Safety & Environmental policies

Education

Bachelor's degree in engineering or science

Tools

SAP Plant Maintenance

eVal/Kneat

ProCal CCMS

Job description

Merck & Co. in Rahway, NJ seeks an on-site Engineering position to support the FLEx Sterile manufacturing area. The role collaborates with Operations, Quality, Engineering, and Maintenance to ensure reliable, compliant sterile production.

Primary focus on Sterile 2, with readiness for Sterile 1 as needed. The incumbent provides QA/QE support across equipment reliability, validation, and lifecycle management, while coordinating with GES, FM/GWES, OEMs and vendors.