Job Title: Associate Manager in MES Operations
In this role, you will be responsible for the implementation and day-to-day operation of the Regeneron Manufacturing Execution System (MES), ensuring the integrity of data within the system and those provided by associated data exchanges.
Key Responsibilities:
* Ensuring MES system installation aligns with site policies and processes
* Coordinating needs of functional groups across the site and establishing priorities for MES operations
* Striving for optimum installation of the system and its continuous process improvement thereafter
* 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 attain a solid understanding of their goals and objectives 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 creating solutions to address them
* Ensuring 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
Requirements:
* Bachelor's degree in a related field
* Minimum 7 years of experience working with MES or manufacturing systems within a life science manufacturing environment
Salary:
$85,000 - $110,000 per year