Senior Specialist, Engineering

Job Description

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.

Primary Responsibilities:

• 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

Education Minimum Requirement: 

• 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.

Required Experience and Skills: 

• 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

Preferred Experience and Skills: 

• 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