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Job Description
Manage and optimize the Regeneron Manufacturing Execution System to ensure seamless operations and data integrity.
Within this role, you will be responsible for the implementation and day-to-day operation of the Regeneron Manufacturing Execution System, ensuring the integrity of the data within the system and those provided by the associated data exchanges. You will be responsible for ensuring that MES operations fully meet the needs of the business by aligning with Commercial Manufacturing requirements. As an Associate Manager in MES Operations, your typical day might include: • Ensuring that MES system installation aligns with site policies and processes • Coordinating the needs of functional groups across the site and establishing priorities for MES operations • Striving for the optimum installation of the system and its continuous process improvement • Reviewing company documentation, including SOPs, requirements, and Manufacturing Batch Records, to assess MES impact • Developing strong business relationships with Commercial Manufacturing, Quality Assurance, and Material Management groups to ensure alignment with MES operations • Collaborating with other IOPS sites on the delivery of the MES system • Developing a strong business relationship with Information Technology to ensure that MES Operations goals and objectives are met • Collaborating with Procurement and IT to build strong working relationships with external vendors and suppliers • Aligning MES business practices with Commercial Manufacturing objectives to anticipate future needs and create solutions to address them • Ensuring that MES Recipe Authoring, Workflows, Electronic Batch Records, etc. are developed and maintained to enable MES operations • Managing and developing MES Operations Analysts • Providing MES Operations support for User Acceptance Testing (UAT) for upgrades and other changes to MES • Reviewing and approving MES Change Controls • Ensuring GxP compliance • Responding to audit inquiries • Collaborating with Commercial Manufacturing and Technical Training to develop and schedule training sessions that best serve the business needs • Providing MES Operations team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals • Providing performance and usage metrics to management and users as required • Delivering strategic updates to senior management as required This role requires: • Knowledge and experience of MES, preferably Werum PAS/X • Logical troubleshooting and problem-solving skills • Excellent analytical, written, and oral communication skills • Ability to work within a successful team 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.