Job Information
Regeneron Pharmaceuticals Manufacturing Engineer (Sterilizing Filter Validation) in East Greenbush, New York
Regeneron is currently looking for a Fill/Finish Manufacturing Engineer. The Fill/Finish MFG Engineer will serve as an expert for formulation, aseptic filling, visual inspection (manual and automated), assembly, and/or packaging processes as assigned, directly supporting the operations team. They will support equipment design and selection as well as process development activities. They will be hands-on, solving issues during technology transfer, cGMP start-up, and routine manufacturing for Regeneron internal operations. This role will also support validation and training activities for the assigned equipment, processes, and operators.
As a Fill/Finish Manufacturing Engineer, a typical day might include the following:
Acting as technical SME for assigned equipment and areas in fill/finish manufacturing facility.
Interfacing with other departments such as Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control.
Leading tech transfer / tech transfer studies, investigations, innovative technology adoption and continuous improvement initiatives.
Crafting and executing cycle development and other studies on manufacturing equipment as defined by end user needs.
Supporting equipment / new technology design, install, and qualification.
Running change parts and recipe creation for new product introduction.
Leading material and component selection, design, and approval. Works with internal stakeholders and external vendors to design, source, and implement materials.
Performing functional evaluation of new components and raw materials for feasibility of use on manufacturing equipment.
Reviewing Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
Supporting SOP development and revision for assigned equipment and process operations.
Driving innovation in fill/finish manufacturing equipment and techniques by staying on top of the latest technological advancements.
Recommending capital expenditures and aiding in the realization of capital projects.
May represent manufacturing during regulatory and client audits.
Tracking and trending relevant technical and business process metrics to ensure operations are performing successfully and efficiently.
Up to 30% travel (domestic and international) may be required (during project phase).
May lead others.
This role may be for you if:
Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
Demonstrated strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
Exhibits confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness.
Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team.
Ability to understand and listen to team members and stakeholders’ needs while supporting a positive team environment
Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred.
Previous experience providing technical support preferred.
Experience with lyophilization is a plus.
Experience with operating and qualifying equipment with high levels of automation is a plus.
In order to be considered for the position, you must hold a BS/BA degree in an Engineering discipline, with relevant experience or equivalent combination of education and experience.
Associate Engineer: BS in engineering with 0+ years industry experience; MS with 0+ years industry experience or equivalent combination of education and experience.
Engineer: BS in engineering with 2+ years industry experience; MS with 1+ years industry experience or equivalent combination of education and experience.
Sr. Engineer: BS in engineering with 4+ years industry experience; MS with 3+ years industry experience or equivalent combination of education and experience.
Experience with sterilizing filter validation is preferred.
Level is determined based on qualifications relevant to the role.
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.
Salary Range (annually)
$58,480.40 - $124,300.00