Job Summary
The role involves implementing and operating the Regeneron Manufacturing Execution System, ensuring data integrity within the system and associated exchanges.
You will be responsible for aligning MES operations with Commercial Manufacturing requirements to meet business needs.
Key Responsibilities:
* Implement and run Regeneron's MES system, adhering to site policies and processes.
* Coordinate with various functional groups to prioritize MES operations.
* Optimize system installation and drive continuous process improvements.
* Review company documentation to assess MES impact on manufacturing.
* Build strong relationships with Commercial Manufacturing, Quality Assurance, and Material Management teams.
* Collaborate with IOPS sites to deliver the MES system.
* Partner with IT to meet MES Operations goals and objectives.
* Establish relationships with external vendors and suppliers.
* Align MES practices with Commercial Manufacturing objectives to anticipate future needs.
* Design and maintain MES Recipe Authoring, Workflows, Electronic Batch Records, etc.
* Support User Acceptance Testing for MES upgrades and changes.
* Review and approve MES Change Controls, ensuring GxP compliance.
* Respond to audit inquiries.
* Collaborate with Commercial Manufacturing and Technical Training to develop training sessions.
* Provide guidance and support to MES Operations team members.
* Deliver performance and usage metrics to management and users.
This role may suit someone with knowledge of MES preferably Werum PAS/X, logical troubleshooting skills, excellent analytical, written and oral communication skills, and experience working in a life science manufacturing environment.
Requirements:
* Bachelor's degree in a related field.
* Minimum 7 years of experience working with MES or manufacturing systems in a life science manufacturing environment.
About Regeneron:
We have an inclusive culture that provides comprehensive benefits, including health and wellness programs, equity awards, annual bonuses, and paid time off. We are an equal opportunity employer and consider all qualified applicants without regard to race, color, religion, sex, nationality, origin, age, disability, or any other protected characteristic.