Job Description:
We are seeking an Associate Manager to lead the implementation and day-to-day operation of our Manufacturing Execution System (MES). This role is responsible for ensuring the integrity of data within the system and those provided by associated data exchanges. The successful candidate will work closely with various functional groups to prioritize MES operations, optimize system installation, and drive continuous process improvements.
Main Responsibilities:
* Implement and run Regeneron's MES system, aligning with site policies and processes.
* Coordinate with functional groups to prioritize MES operations and optimize system installation.
* Review company documentation to assess MES impact and build strong business relationships with key stakeholders.
* Collaborate with other IOPS sites to deliver the MES system and partner with IT to meet MES Operations goals and objectives.
* Align MES practices with Commercial Manufacturing objectives to anticipate and address future needs.
* Design and maintain MES Recipe Authoring, Workflows, Electronic Batch Records, etc.
* Support User Acceptance Testing (UAT) for MES upgrades and changes.
* Review and approve MES Change Controls, ensuring GxP compliance.
* Respond to audit inquiries and collaborate with Commercial Manufacturing and Technical Training to develop and schedule training sessions.
* Provide guidance and support to MES Operations team members.
* Deliver performance and usage metrics to management and users.
* Provide strategic updates to senior management.
Requirements:
* Bachelor's degree in a related field and minimum 7 years of experience working with MES or manufacturing systems within a life science manufacturing environment.
* Demonstrated knowledge and experience of MES preferably Werum PAS/X.
* Logical troubleshooting and problem-solving skills.
* Excellent analytical, written, and oral communication skills.
About Us:
We have an inclusive and diverse culture that provides comprehensive benefits. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, national or ethnic origin, civil status, age, citizenship status, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, or any other protected characteristic.