Specialist, Automation Engineering - 2nd Shift (Onsite)

MSD•Rahway, NJ

3d•$87,300 - $137,400•Onsite

About The Position

The Specialist, Automation Engineering provides end-to-end automation engineering support for the Rahway, New Jersey FLEx Center, primarily supporting sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply and Pharmaceutical Operations Engineering. The role helps ensure reliable, compliant process automation and OT/IT systems for formulation, filling, lyophilization, and related activities involving clinical and development sterile products. It supports operational start-up and new capital investments, including automation lifecycle management, data and analytics, and site representation on capital projects. This is an onsite role reporting directly to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead. Intermittent off-shift, weekend, or extended-shift work is required to support manufacturing operations. The role maintains automation systems in a validated state and provides manufacturing-floor troubleshooting, root cause analysis, reliability improvements, change control, investigations, and audit support. It leads or participates in automation project and lifecycle activities, from planning and design through installation, integration, testing, commissioning, and qualification. The Specialist works with manufacturing, quality, engineering, facilities, IT, security, vendors, and system integrators to deliver compliant, scalable, supportable systems and to improve operations through data, reporting, analytics, and visualization. The facility supports clinical and developmental sterile products across modalities including small molecules, biologics, vaccines, and antibody-drug conjugates. Its work includes start-up operations and a new capital expansion. The employer describes itself as a research-driven biopharmaceutical company focused on medicines and vaccines for patients worldwide.

Requirements

Bachelor’s degree in Engineering, Science, Information Technology, or a related field.
At least 2 years of experience in process automation or equivalent.
Strong knowledge of cGMP, quality systems, safety, environmental requirements, data integrity, and validation principles for automation and computer systems.
Hands-on experience maintaining validated automation systems and performing change control, investigations/CAPA, periodic reviews, and GMP system administration, including user/role management, patching, backups, and virtualization.
Experience with cybersecurity within GMP operations.
Proficiency with PLC/SCADA and industrial networking fundamentals, with the ability to troubleshoot controls, instrumentation, electrical, and software layers.
Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams.
Demonstrated root cause analysis and problem-solving skills and a continuous improvement mindset.
Demonstrated strong performance and excellent project management skills.
Highly developed communication and teamwork skills.

Nice To Haves

Experience with Allen-Bradley and/or Siemens PLCs; SCADA systems such as iFix, WinCC OA, or Ignition; OPC; fieldbuses such as ASI, Profibus, Profinet, or DeviceNet; instrumentation; and panel design.
Programming experience with Ladder Logic, Sequential Function Charts, Python, or other scripting for automation, testing, and reporting.
Knowledge of S88 batch standards.
Experience in biologics, vaccine, or bulk sterile manufacturing facilities; these backgrounds are strongly preferred.
OT/IT experience with industrial networking, virtualization such as VMs, databases/historians, and basic system administration.
Experience with electronic validation and quality systems such as Kneat/eVal or Veeva.
Prior leadership of installation, integration, and qualification of automated equipment, and experience on capital projects in GMP environments.
Familiarity with planning and scheduling practices, vendor management, and business or financial acumen for project delivery.
A track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting.
Experience supporting audits and inspections and authoring or reviewing SOPs and validation protocols or reports.
Continuous improvement, cross-functional teamwork, and PLC automation skills.

Responsibilities

Maintain automation systems in a validated, compliant state in accordance with cGMP, safety, data integrity, cybersecurity, and lifecycle practices, including commissioning, qualification, change control, obsolescence, and periodic reviews.
Provide end-to-end operational support for sterile clinical manufacturing, including on-floor troubleshooting, root cause analysis, and improvements to performance and batch reliability.
Implement and sustain platform automation solutions, reporting, and visualization; keep documentation, SOPs, drawings, configurations, preventive maintenance records, and inventories inspection-ready.
Lead and participate in automation system changes, investigations, and CAPAs; represent automation and data integrity during internal and external audits and inspections.
Develop and execute automation change controls, including change definition, risk and impact assessments, task execution, implementation, and support for associated regulatory filings.
Serve as the 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 and ensure OT/IT architecture, cybersecurity, data integrity, and validation requirements are reflected in project scope and deliverables.
Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification (AIOQ) of automated equipment and systems; author or execute URS, RS, CS, DS, AIQ, AOQ, AIOQ, and UAT documentation and activities.
Evaluate and plan automation and IT expansions, replacements, upgrades, and obsolescence remediation to support quality, stability, scalability, and supportability.
Partner with enterprise and divisional IT, global infrastructure, and risk/security teams on standards and GMP system administration, including user and role administration, patching, backups, disaster recovery, and virtualization.
Collaborate with GES, FM/GWES, Quality, Manufacturing Operations, OEM vendors, and system integrators to deliver reliable, compliant automation operations.
Supervise and coordinate contract engineers and vendors and manage their workload and deliverables.
Develop and support data, reporting, analytics, and visualization solutions using historian and SCADA sources to monitor asset health and improve reliability.
Troubleshoot across controls, instrumentation, electrical, software, and industrial networking layers; apply lean and continuous improvement principles to stabilize and optimize automation system performance.
Provide automation support for manufacturing operations during intermittent second-shift, weekend, or extended-shift periods.