Job Description:
Role Summary:
The Associate Manager in MES Operations is responsible for implementing and operating the Regeneron Manufacturing Execution System, ensuring data integrity and aligning MES operations with Commercial Manufacturing requirements.
Key Responsibilities:
* Ensure MES system installation aligns with site policies and processes
* Coordinate functional group needs across the site and establish priorities for MES operations
* Optimize system installation and continuous process improvement
* Review company documentation to assess MES impact
* Develop business relationships with Commercial Manufacturing, Quality Assurance, and Material Management groups
* Collaborate with other IOPS sites on MES delivery
* Build strong working relationships with external vendors and suppliers
* Align MES business practices with Commercial Manufacturing objectives
* Manage and develop MES Operations Analysts
* Provide MES Operations support for User Acceptance Testing (UAT)
* Review and approve MES Change Controls
* Ensure GxP compliance
* Respond to audit inquiries
* Develop and schedule training sessions with Commercial Manufacturing and Technical Training
* Provide guidance and support to MES Operations team members
* Deliver strategic updates to senior management
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
* Knowledge and experience of MES preferably Werum PAS/X
* Logical troubleshooting and problem-solving skills
* Excellent analytical, written, and oral communication skills