Within this role you will perform 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, organize the purchase, delivery & installation of cleanroom furniture and storage, liaising with external vendors, lead /support Manufacturing projects relating to small equipment introduction, qualification etc. Performs people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.
As a Sr equipment Specialist, a typical day may include, but are not limited to, the following:
This is a straight days position, Monday - Friday.
The qualification of small equipment by liaising with multiple vendors, review and sign-off of qualification packages, completing BMRAM activities including ECN builds and PM event builds for multiple pieces of equipment.
Generation of System Impact Assessments and System Requirement Specifications for new equipment and update old equipment SRS/ SIA. Defining standards, controls, and procedures across the lifecycle of documents.
Contact external vendors to come on site, organize induction, organize safe permit for work and supervise and approve vendor works.
Review vendor Method Statements & Risk Assessments. Liaise with EHS regrading having these approved.
Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
Equipment SME with respect to data integrity, audit and manages upgrades. Implements data integrity requirements within project documentation
Leads and coordinates equipment qualification projects from initiation to completion.
Applying standards, controls, and procedures across the lifecycle of documents.
Support / lead small manufacturing projects as / when required.
Support NPI.
Manages Implementation of supplemental qualification to existing systems.
Performs 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:
Strong analytical skills with the ability to collect, organize, analyze, and disseminate information with attention to detail and accuracy.
Background in equipment qualification is preferred.
Can work both independently as an original thinker and in a team setting.
Strong communication skills and leadership skills.
Level commensurate with experience
To be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience.
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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.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.