Specialist, Automation Engineering
Merck
August 26, 2026
On-site
Rahway, NJ
Operations
Primary Responsibilities
- Maintain validated, compliant automation systems (cGMP, safety, data integrity, cybersecurity) using lifecycle practices (commissioning, qualification, change control, obsolescence, periodic reviews).
- Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization): troubleshooting, root-cause analysis, and reliability improvements.
- Implement and sustain automation solutions (reporting/visualization); keep documentation/SOPs/drawings/configurations/PMs inspection-ready.
- Lead/participate in automation changes, investigations, CAPAs; represent automation/data integrity during audits/inspections.
- Execute automation change control and support associated regulatory filings.
- Lead cross-functional teams; represent automation in capital projects (OT/IT architecture, cybersecurity, data integrity, validation).
- Lead installation/integration/FAT-SAT/commissioning/qualification (AIOQ) and author/execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT.
- Evaluate and plan automation/IT upgrades/replacements and obsolescence remediation.
- Develop historian/SCADA-based analytics; troubleshoot controls/instrumentation/software/networking.
Qualifications
- Bachelor’s in Engineering/Science/IT or related; minimum 2 years process automation experience (or equivalent).
- cGMP, Quality Systems, safety, data integrity, validation knowledge.
- Hands-on validated automation maintenance, change control, investigations/CAPA, periodic reviews, system administration, cybersecurity in GMP.
- PLC/SCADA and industrial networking fundamentals; strong technical writing and communication.
Preferred
- Allen-Bradley/Siemens PLCs, SCADA (iFix/WinCC OA/Ignition), OPC, fieldbuses; Python/scripting; S88; sterile biologics/vaccine experience; OT/IT (virtualization/databases/historians); electronic validation tools (Kneat/eVal/Veeva); capital project automation leadership.
Education/Experience Skills
- Project management, root cause analysis, continuous improvement.
Benefits (if applicable)
- Medical, dental, vision; retirement (401(k)); paid holidays, vacation, compassionate and sick days.
Application
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).
- Maintain validated, compliant automation systems (cGMP, safety, data integrity, cybersecurity) using lifecycle practices (commissioning, qualification, change control, obsolescence, periodic reviews).
- Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization): troubleshooting, root-cause analysis, and reliability improvements.
- Implement and sustain automation solutions (reporting/visualization); keep documentation/SOPs/drawings/configurations/PMs inspection-ready.
- Lead/participate in automation changes, investigations, CAPAs; represent automation/data integrity during audits/inspections.
- Execute automation change control and support associated regulatory filings.
- Lead cross-functional teams; represent automation in capital projects (OT/IT architecture, cybersecurity, data integrity, validation).
- Lead installation/integration/FAT-SAT/commissioning/qualification (AIOQ) and author/execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT.
- Evaluate and plan automation/IT upgrades/replacements and obsolescence remediation.
- Develop historian/SCADA-based analytics; troubleshoot controls/instrumentation/software/networking.
Qualifications
- Bachelor’s in Engineering/Science/IT or related; minimum 2 years process automation experience (or equivalent).
- cGMP, Quality Systems, safety, data integrity, validation knowledge.
- Hands-on validated automation maintenance, change control, investigations/CAPA, periodic reviews, system administration, cybersecurity in GMP.
- PLC/SCADA and industrial networking fundamentals; strong technical writing and communication.
Preferred
- Allen-Bradley/Siemens PLCs, SCADA (iFix/WinCC OA/Ignition), OPC, fieldbuses; Python/scripting; S88; sterile biologics/vaccine experience; OT/IT (virtualization/databases/historians); electronic validation tools (Kneat/eVal/Veeva); capital project automation leadership.
Education/Experience Skills
- Project management, root cause analysis, continuous improvement.
Benefits (if applicable)
- Medical, dental, vision; retirement (401(k)); paid holidays, vacation, compassionate and sick days.
Application
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).