Sterile Engineering Specialist – Onsite (1st Shift)

MSD

Rahway (NJ)

On-site

USD 87,000 - 137,000

Full time

3 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an on-site Engineer to support the FLEx Sterile manufacturing area, focusing on qualification, validation, and lifecycle management of equipment and utilities.

You will collaborate across Operations, Quality, Engineering, and external vendors to enable compliant manufacturing. The role emphasizes GMP, risk-based validation, and maintenance planning, with opportunities to contribute to capital projects and process development within a regulated

Qualifications

Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
Familiarity with Sterile Drug Product manufacturing equipment and process.
Familiarity with Computerized Maintenance and Management Systems (CMMS).
Troubleshooting ability (mechanical/electrical/automation).
Ability to adapt across Quality and Facility aspects; strong organizational skills.
Effective communication and technical writing skills; strong 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.
Apply reliability-centered maintenance to ensure equipment availability.
Serve as SME for sterilization and cleaning validation programs; coordinate with third parties.