Senior Specialist, Engineering

Merck & Co.-posted about 1 month ago
Full-time • Mid Level
Onsite • Rahway, NJ
5,001-10,000 employees
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The Senior Automation Specialist provides end-to-end automation and quality engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures reliable, compliant operation of process automation and OT/IT systems that enable formulation, filling, and support activities for clinical and development sterile products. This position supports start-up operations (FLEx) and new capital builds, including automation lifecycle management, data/analytics, and site representation on capital projects. Some off-shift work (second shift and weekends) will be required to support manufacturing operations.

  • Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews)
  • Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling), including on-floor troubleshooting, root cause analysis, and performance/batch reliability improvements
  • Implement and sustain platform automation solutions, reporting, and visualization to meet operational and compliance needs; keep documentation, SOPs, drawings, configurations, PMs, and inventories inspection-ready
  • Lead and participate in automation system changes, investigations, CAPAs; represent automation and data integrity during internal/external audits and inspections
  • Serve as site automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive continuous improvement
  • Represent automation in capital projects, embedding OT/IT architecture, cybersecurity, data integrity, and validation requirements in project scope and deliverables
  • Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification of new automated equipment and systems; author/execute URS/DS/IQ/OQ/PQ
  • Evaluate and plan automation/IT expansions, replacements, upgrades, and obsolescence remediation to ensure quality, stability, scalability, and supportability
  • Partner with enterprise/divisional IT, global infrastructure, and risk/security to align standards and manage user/role administration, patching, backups, disaster recovery, and virtualization in GMP operations
  • Collaborate with GES, FM/GWES, Quality, Manufacturing Operations, OEMs, system integrators, and vendors to deliver reliable, compliant automation operations; supervise and coordinate contract engineers/vendors and manage workload and deliverables
  • Develop and support data, reporting, analytics, and visualization solutions using historian/SCADA sources to monitor asset health and drive reliability improvements
  • Troubleshoot across controls, instrumentation, electrical, software, and industrial networking layers; apply lean and continuous improvement principles to stabilize and optimize automation performance
  • BS in Engineering, Science, or Information Systems, plus a minimum of 5 years of related technical support or manufacturing automation experience or acceptable related experience.
  • Strong knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems
  • Hands-on experience maintaining validated automation systems, executing change control, investigations/CAPA, periodic reviews, system administration (e.g., user/role management, patching, backups, virtualization), and cybersecurity within GMP operations
  • Proficiency with PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers
  • Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams
  • Proven root cause analysis and problem-solving skills; continuous improvement mindset
  • Platforms/technologies: Allen-Bradley and/or Siemens PLCs; SCADA (iFix, WinCC OA, Ignition); OPC; fieldbuses (ASI/Profibus/Profinet/DeviceNet); instrumentation and panel design
  • Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting
  • OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration
  • Experience with electronic validation and quality systems (e.g., Kneat/eVal, Veeva)
  • Prior leadership of installation/integration/qualification of automated equipment; experience on capital projects in GMP environments
  • Familiarity with planning/scheduling practices, vendor management, and business/financial acumen for project delivery
  • Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting
  • Demonstrated experience supporting audits/inspections and authoring/reviewing SOPs, validation protocols/reports (e.g., URS/FS/IQ/OQ/PQ)
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
  • We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
  • More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits
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