Within this role, you will be responsible for implementing and managing the Regeneron Manufacturing Execution System, ensuring data integrity and aligning MES operations with Commercial Manufacturing requirements.
Key Responsibilities
* Ensure MES system installation meets site policies and processes.
* Coordinate functional group needs across the site and prioritize MES operations.
* Optimize MES system installation and continuously improve its process.
* Review company documentation to assess MES impact.
* Develop strong relationships with Commercial Manufacturing, Quality Assurance, and Material Management groups.
* Collaborate with other IOPS sites on MES delivery.
* Build a strong working relationship with Information Technology.
* 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.
* Collaborate with Commercial Manufacturing and Technical Training to develop training sessions.
* Guide and support MES Operations team members.
* Provide performance and usage metrics to management and users.
* Deliver strategic updates to senior management.
Requirements
* Demonstrate knowledge and experience of MES preferably Werum PAS/X.
* Possess logical troubleshooting and problem-solving skills.
* Have excellent analytical, written, and oral communication skills.
* Demonstrate an ability to work within a successful team.
Qualifications
To be considered for this opportunity, you should have a BA/BS in a related area and a minimum of 7 years of experience working with MES or manufacturing systems within a life science manufacturing environment or equivalent combination of education and experience.