Providing technical support on the upstream manufacturing process for a Process Area Project. Key member in the design and implementation of new large scale commercial 10KL state of the art production area.
As a Manufacturing Process Specialist-Upstream a typical day might include, but is not limited to, the following:
Liaising with the engineering/automation design team in relation to the design, qualification and startup of the upstream manufacturing process.
Helping structure detailed process designs to support the build of the new DCS system Delta V
Defining the structure of the integration of both the DCS and MES system
Supporting the designing of new DCS bioreactor recipes to integrate with Delta V
Acting as an equipment/process SME for HAZOP sessions to support the safe design of the plan
Supporting FAT and SAT for both equipment and automation
Supporting the safe start up and commissioning of the new process equipment.
Owning the qualification of small equipment for the new process area
Managing GMP area release of the production area
Providing technical input into electronic MBR’s, batch sheets and procedures.
Writing &reviewing new electronic Standard Operating Procedures or other controlled documents for the newly automated process area
Communicating with project team regarding changes to the process or material used within the process
Working with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control
Working to the highest safety standards and supporting safety implementations from the design process
Supporting all aspects of the upstream manufacturing process according to approved protocols, regulation, and schedule
Supporting investigations into process variances according to site procedures
This role might be for you if:
You have strong Upstream Process knowledge or a SME with Upstream Processing
You have deep Technical knowledge cGMP manufacturing
You have the ability to maintain integrity and honesty at all times
you have strong project management experience and the ability to balance multiple projects, prioritise them and execute them thoughtfully and independently
To be considered for this position you must hold a BS/BA/BEng or higher with Life Sciences or other related discipline. For Specialist level you must have 3+ years practical experience working in Upstream Process area. For Sr Specialist you must have 5+ years practical experience working in Upstream Process area
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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.
