Automation Engineer - Sterile Manufacturing & Compliance

MSD

Rahway (NJ)

On-site

USD 87,000 - 137,000

Full time

5 days ago

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Job summary

MSD Rahway, NJ is seeking a Specialist, Automation Engineering to support sterile clinical manufacturing at the FLEx Center. You'll maintain validated automation systems, lead changes, and ensure data integrity and cGMP compliance across OT/IT in a fast‑paced startup‑like environment.

This onsite role requires a BS in engineering, at least 2 years of automation experience, and strong collaboration to drive capital projects, troubleshooting, and continuous improvement in a multinational pharma

Qualifications

Bachelor’s degree in Engineering or related field.
Minimum 2 years of experience in process automation or equivalent.
Strong project management and communication skills.
Demonstrated performance in cGMP, quality systems, safety, and data integrity.

Responsibilities

Maintain automation systems in a validated, compliant state per cGMP and lifecycle practices.
Provide end-to-end operations support for sterile clinical manufacturing (formulation, filling, lyophilization).
Lead automation changes, CAPAs, and investigations; represent automation in audits.
Develop and execute automation change control including risk assessments and regulatory filings.
Coordinate installation, integration, FAT/SAT, commissioning, and qualification of new equipment.
Collaborate with IT and QA to align standards and manage user administration, backups, and virtualization.