Within this role you will be responsible for the overall system maintenance and on-going support of the Manufacturing Execution Systems (MES). The individual provides MES configuration and support services to meet end-user needs. Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a validated state.As a Senior MES Operations Analyst, a typical day might include, but is not limited to, the following:
Provides MES configuration and support services to meet end-user needs
Processes system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state
Coordinates the needs of functional departments and establishes priorities for MES requirements gathering, system design and implementation
Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle, including User Requirement Specifications, Functionality Specifications, and Configuration Specifications
Reviews company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess impact to MES related IT infrastructure and processes
Works with Validation and Quality Assurance departments to ensure MES is implemented following development life cycle approach
Provides end-user support for the MES including troubleshooting problems at the application server level
Performs User Management and system administration functions in MES
Recommends and installs systems updates, patches, services packs, and hot fixes
Monitors applications for readiness, availability, and performance trend analysis
Maintains disaster recovery environment and ensure periodic testing is performed
Logs application support incidents and prepares appropriate resolution plans
This role might be for you if:You demonstrate knowledge and experience of MES preferably Werum PAS/XYou possess logical troubleshooting and problem-solving skillsYou have excellent analytical, written and oral communication skillsYou demonstrate an ability to work within a successful teamTo be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 5+ years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience.#REGNIELSM #LI-Onsite #IRELIM #JOBSIESTDoes 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.S.-based 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.
