Associate Specialist, Engineering providing end-to-end automation engineering support at FLEx Center in Rahway, NJ. Ensuring compliance and reliability of process automation and OT/IT systems in sterile clinical manufacturing.
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
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)
Maintain automation systems in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current Good Manufacturing Practices
Troubleshoot challenging equipment/automation issues to improve equipment/automation system performance to support PSIM readiness
Requirements
BS in Engineering science, computer science, or Information system
Knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems
Basic understanding of PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers
Proven root cause analysis and problem-solving skills; continuous improvement mindset
Strong technical writing capabilities
Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers and vendors.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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