Job Description
Within this role you will beresponsible for the implementation and day to day operation of the Regeneron Manufacturing Execution System, 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 meets the needs of the business by aligning with Commercial Manufacturing requirements. As an Associate Manager in MES Operations a typical day might include, but is not limited to, the following: Ensuring that MES system installation aligns with site policies and processes Coordinating the needs of functional groups across the site and establishing the priorities for MES operations Striving for the 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 Industrial Operations and Product Supply (IOPS) sites on the delivery of the MES system Developing a strong business relationship with IT 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 that MES Recipe Authoring, Workflows, Electronic Batch Records, etc. are developed and maintained to enable MES operations 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 might be for you if: You demonstrate knowledge and experience of MES preferably Werum PAS/X You possess logical troubleshooting and problem-solving skills You have excellent analytical, written and oral communication skills You demonstrate an ability to work within a successful team To be considered for this opportunity you should have a BA/BS in 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. #REGNIELSM #JOBSIEST Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.