Senior Specialist, Engineering providing automation support for clinical manufacturing processes at FLEx Center in Rahway, NJ. Ensuring reliable operation of automation systems and leading capital projects.
Responsibilities
Provide end-to-end automation engineering support for the Rahway, NJ FLEx Center
Ensure the reliable and compliant operation of process automation and OT/IT systems
Maintain automation systems in a validated, compliant state per cGMP
Lead and participate in automation system changes, investigations, CAPAs
Develop and execute automation change control
Serve as site automation representative for new products and operational improvements
Represent automation in capital projects
Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification of new automated equipment
Requirements
BS in Engineering, Science, or Information Systems
minimum of 5 years of related technical support or manufacturing automation experience
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
Proficiency with PLC/SCADA and industrial networking fundamentals
Strong interpersonal, communication, and technical writing skills
Proven root cause analysis and problem-solving skills
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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