Associate Manager in MES Operations
This role is responsible for the implementation and day-to-day operation of the Regeneron Manufacturing Execution System, ensuring data integrity within the system and those provided by associated data exchanges.
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.
* Strive for optimal system installation and continuous process improvement.
* Review company documentation, including SOPs, requirements, and Manufacturing Batch Records, to assess MES impact.
* Develop strong business relationships with Commercial Manufacturing, Quality Assurance, and Material Management groups to ensure alignment with MES operations.
* Collaborate with other IOPS sites on the delivery of the MES system.
* Establish a strong business relationship with Information Technology to ensure MES Operations goals and objectives are met.
* Collaborate with Procurement and IT to build working relationships with external vendors and suppliers.
* Align MES business practices with Commercial Manufacturing objectives to anticipate future needs and create solutions.
* Ensure MES Recipe Authoring, Workflows, Electronic Batch Records, etc. are developed and maintained to enable MES operations.
* Manage and develop MES Operations Analysts.
* Provide MES Operations support for User Acceptance Testing (UAT) for upgrades and changes to MES.
* Review and approve MES Change Controls.
* Ensure GxP compliance.
* Respond to audit inquiries.
* Collaborate with Commercial Manufacturing and Technical Training to develop and schedule training sessions.
* Guide and support team members to ensure they have the skills and tools required to support business needs and individual professional goals.
* Provide performance and usage metrics to management and users as required.
* Deliver strategic updates to senior management as required.
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.