Specialist, Automation Engineering

Fluorine Laboratory, Experiments (FLEx) Center in Rahway, New Jersey houses a cutting‑edge sterile drug product cGMP clinical supply manufacturing facility, FLEx Sterile, currently in operational start‑up phase. The facility supports formulation, filling, lyophilization, and associated activities for a range of product modalities – sterile small molecules, biologics, vaccines, and antibody‑drug conjugates (ADCs) – to deliver our clinical pipeline to patients worldwide. 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/lyophilization), 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. 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/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. Education Minimum Requirement Bachelor’s degree in an Engineering, Science, Information Technology, or related field and a minimum of 2 years of experience in process automation or equivalent. Demonstrated strong performance record and excellent project management skills. Highly developed communication and teamwork skills. 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 (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 and a 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 reporting. Knowledgeable of S88 batch standards. Experience in biologics, vaccine or bulk sterile manufacturing facilities is strongly preferred. 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 and 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. Compensation and Benefits Salary range: $87,300.00 - $137,400.00. Employees may be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive benefits package, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. #J-18808-Ljbffr Merck