Regeneron Manufacturing Execution System Specialist
6 days ago
Job Summary:
The Associate Manager MES Operations 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 associated data exchanges. This role will align MES operations with Commercial Manufacturing requirements, ensuring that the system meets the needs of the business.
Key Responsibilities:
- Ensure that MES system installation aligns with site policies and processes.
- Coordinate the needs of functional groups across the site and establish priorities for MES operations.
- Strive for the optimum installation of the system and its continuous process improvement thereafter.
- 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.
- Develop a strong business relationship with Information Technology to ensure that MES Operations goals and objectives are met.
- Collaborate with Procurement and IT to build strong working relationships with external vendors and suppliers.
- Align MES business practices with Commercial Manufacturing objectives to anticipate future needs and create solutions to address them.
- Ensure that 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 other 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 that best serve the business needs.
- Provide 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.
- Provide performance and usage metrics to management and users as required.
- Deliver strategic updates to senior management as required.
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.
Education and Experience:
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 an equivalent combination of education and experience.
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