Senior Specialist, Automation Engineering; Onsite

Senior Specialist, Automation Engineering

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, is a cutting‑edge sterile drug product cGMP clinical supply manufacturing facility currently in the operational start‑up phase. FLEx Sterile will deliver our clinical pipeline worldwide, supporting sterile small molecules, biologics, vaccines, and antibody‑drug conjugates (ADCs). The role provides end‑to‑end automation engineering support for sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply, ensuring reliable and compliant operation of process automation and OT/IT systems for formulation, filling, lyophilization, and related activities.

• 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, 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; maintain 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.
• Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• 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 (AIOQ) of new automated equipment and systems; author and execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT.
• 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 (product/equipment QA and digital data quality – DDQ), Manufacturing Operations, OEM vendors/system integrators 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 system performance.
• Off‑shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.

• BS in Engineering, Science, or Information Systems with a minimum of 5 years of related technical support or manufacturing automation experience.
• Demonstrated strong performance record and excellent project management skills.
• Highly developed communication, leadership, and teamwork 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…