Job Description
The Manufacturing Equipment Specialist performs tasks related to the set-up and start-up of manufacturing operations (Large Scale & Sub-Suites); primarily, the qualification of Manufacturing Small Equipment, review and approval of equipment qualification packages, purchase, delivery & installation of cleanroom furniture and storage, liaising with external vendors, lead / support projects relating to small equipment introduction and qualification. As a Manufacturing Equipment Specialist, a typical day may include, but is not limited to, the following: Qualifying small equipment by liaising with multiple vendors, reviewing and signing off of qualification packages, completing BMRAM activities including ECN builds and PM event builds for multiple pieces of equipment Generating System Impact Assessments and System Requirement Specifications for new equipment and updating old equipment SRS/SIA Defining standards, controls and procedures across the lifecycle of documents Contacting external vendors to come on-site, organizing induction, organizing safe permit for work and supervising and approving vendor works Reviewing vendor Method Statements & Risk Assessments and liaising with EHS regrading approvals of same Interfacing with other departments such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control Acting as equipment SME with respect to data integrity, audit and managing upgrades Implementing data integrity requirements within project documentation Leading and coordinating equipment qualification projects from initiation to completion Applying standards, controls, and procedures across the lifecycle of documents Supporting and leading small manufacturing projects when required Supporting NPI Managing implementation of supplemental qualification to existing systems Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations and performance evaluations The role may be for you if: You have a background in equipment qualification You have strong analytical skills with the ability to collect, organize, analyze and disseminate information with attention to detail and accuracy You can work both independently as an original thinker and in a team setting You have strong communication skills and leadership skills To be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 2+ years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience. #REGNIELSM #JOBSIEST #REGNIEEC 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.