Associate Specialist, Engineering (Onsite)

Role Summary

The Associate Specialist, Engineering – Automation role provides end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on sterile clinical manufacturing. The role ensures reliable, compliant operation of process automation and OT/IT systems that enable formulation, filling, lyophilization, and related activities for clinical and development sterile products. It supports start-up operations and new capital investments in the clinical supply area and is an onsite position reporting to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead. Off-shift or extended shift work may be required on an intermittent basis to support manufacturing operations.

Responsibilities

• Work closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support.
• Support the successful implementation of automation solutions, including both platform technologies and associated reporting needs.
• Execute / develop appropriate system validation, change control and user test acceptance documents (UAT).
• Lead/participate in installation, integration, FAT/SAT, commissioning, and qualification of new automated equipment and systems for new capital project line (FLEx sterile 2); author/execute URS/RS/CS/DS/AIOQ/UAT.
• Support a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes.
• Maintain automation systems in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current Good Manufacturing Practices.
• Implement system changes and conduct system investigations.
• Active and engaged participation in the site tier processes (routine operations support processes) as well as supporting a culture of continuous improvement at the site.
• Troubleshoot challenging equipment/automation issues to improve equipment/automation system performance to support PSIM readiness.
• Provide support as a representative on a startup or existing production team providing technical assistance in fulfilling the automation requirements for the team.
• Review automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with Good Manufacturing Practice and safety.
• Support and execute corrective actions for investigations related to automation/OT or IT systems.
• Develop and maintain automation and computer system validation specific standard operating procedures (SOPs).
• Perform automation system periodic reviews (PR) and system user annual reviews.
• Develop technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems.
• Provide on-floor support of clinical manufacturing activities.
• Provide client services support for business area applications.
• Off-shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.

Qualifications

• Required: Knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems.
• Required: Basic understanding of PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers.
• Required: Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams.
• Required: Proven root cause analysis and problem-solving skills; continuous improvement mindset.
• Required: Strong technical writing capabilities.
• Required: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers and vendors.
• Preferred: Platforms/technologies: Allen-Bradley and/or Siemens PLCs; SCADA (iFix, WinCC OA, Ignition); OPC; fieldbuses (ASI/Profibus/Profinet/DeviceNet); instrumentation and panel design
• Preferred: Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting
• Preferred: Knowledgeable of S88 batch standards.
• Preferred: Experience in biologics, vaccine or bulk sterile manufacturing facilities is plus.
• Preferred: OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration
• Preferred: Demonstrate a strong performance record
• Preferred: Highly developed communication and teamwork skills
• Preferred: Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting
• Preferred: Direct impact enabling sterile product development from lab to clinic through robust, compliant automation
• Preferred: Ownership across automation lifecycle, troubleshooting, and capital initiatives
• Preferred: Collaboration with world-class operations, quality, engineering, IT, and security teams

Education

• BS in Engineering science, computer science, or Information system

Skills

• Required Skills: Adaptability, Applied Engineering, Automated Manufacturing Systems, Biopharmaceutical Operations, CAD Proficiency, Communication, Computer Engineering, Computer Science, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, GMP Compliance, Healthcare Innovation, Interpersonal Communication, IT Demand Management, Prioritization, Process Automations, Process Optimization, Professional Engineering, Project Management, Software Proficiency, Teamwork

Additional Requirements

• Travel Requirements: No Travel Required
• Shift: 1st - Day
• Location: Rahway, NJ (onsite)