Summary: Responsible for the Design and Configuration of the Manufacturing Execution Systems (MES) manufacturing Batch Records and Equipment data. The successful individual is responsible for eliciting and documenting manufacturing business processes requirements
Essential Duties and Responsibilities include, but are not limited to, the following:
Design and deploy MES system (Werum’s PAS-X) to replace paper based process or manual processes in the processing areas
Coordinates the needs of functional departments and establishes priorities for MES User requirements gathering, system design and implementation
Actively participate in project deliverables such as Review of company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess requirements for designing electronic records
Design and develop MES recipes, workflows, Equipment, Master Data and electronic batch records to meet the requirements of the Business, specifically Manufacturing and QA
Participates in the Creation and Testing of MES related protocols
Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle
Processes system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state
Liaise with Technical Trainers to develop training plans for MES users
Provides end-user support for the MES including troubleshooting problems on the floor and work closely with IT to troubleshoot problems
Implement strategies to improve process efficiencies
Knowledge and Skills:
Knowledge of BioPharma Manufacturing and Supply Chain Process
Knowledge and experience of MES preferably Werum PAS/X In depth knowledge of concepts of GMP, ICH guidelines and GAMP requirements
An understanding of the project lifecycle and of quality management processes Logical troubleshooting and problem solving skills Excellent analytical, written and oral communication skills
Education and Experience: BS/BA/BEng in a Technical Discipline required, with 2+ years of experience working within a Life Sciences manufacturing environment. Will substitute relevant industry experience in lieu of educational requirement
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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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.