Sterile GMP Automation Engineer - 2nd Shift Onsite

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

Job summary

Merck & Co. Rahway, NJ, is seeking an Automation Engineering Specialist to provide end-to-end automation support for sterile clinical manufacturing at the FLEx Sterile facility.

The role focuses on OT/IT systems, lifecycle management, and regulatory compliance in a start-up/expansion environment. The position requires a Bachelor’s degree in an engineering or related field, 2+ years in process automation, and strong collaboration across IT, QA, and operations.

Qualifications

• Bachelor's degree in an Engineering, Science, Information Technology, or related field.
• Minimum 2 years of experience in process automation or equivalent.
• Demonstrated a strong performance record and have excellent project management skills.
• Highly developed communication, teamwork skills.

Responsibilities

• Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices.
• Provide end-to-end operations support for sterile clinical manufacturing, including on-floor troubleshooting and root cause analysis.
• Lead automation changes, CAPAs, and participate in audits and inspections.
• Develop and execute automation change control inclusive of risk assessments, impact assessments, and regulatory filings.

Skills

cGMP knowledge

Data integrity

System validation

Automation lifecycle management

Root cause analysis

Cybersecurity awareness

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, Information Technology, or related field

Tools

Allen-Bradley PLCs

Siemens PLCs

SCADA (iFix, WinCC OA, Ignition)

OPC

Industrial networking fundamentals

Job description

Merck & Co. Rahway, NJ, is seeking an Automation Engineering Specialist to provide end-to-end automation support for sterile clinical manufacturing at the FLEx Sterile facility.

The role focuses on OT/IT systems, lifecycle management, and regulatory compliance in a start-up/expansion environment. The position requires a Bachelor’s degree in an engineering or related field, 2+ years in process automation, and strong collaboration across IT, QA, and operations.