仕事内容
The Fill/Finish MFG Engineer will serve as an expert for packaging processes, equipment, and associated materials, 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 MFG Engineer, a typical day might include the following:
- Acts as a technical SME for packaging areas within fill/finish manufacturing.
- Interfaces with other departments such as Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control.
- Acts as the Manufacturing lead for tech transfer / tech transfer studies, investigations, innovative technology adoption and continuous improvement initiatives.
- Designs and executes process development and other studies on manufacturing equipment as defined by end user needs.
- Supports equipment / new technology design, install, and qualification.
- Manages change parts and recipe creation for new product introduction.
- Leads material and component selection, design, and approval. Works with internal stakeholders and external vendors to design, source, and implement materials.
- Performs functional evaluation of new components and raw materials for feasibility of use on manufacturing equipment.
- Reviews Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
- Supports SOP development and revision for assigned equipment and process operations.
- Drives innovation in fill/finish manufacturing equipment and techniques by keeping abreast of latest technological advancements.
- Recommends capital expenditures and aids in the realization of capital projects.
- May represent manufacturing during regulatory and client audits.
- Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
- Up to 30% travel (domestic and international) may be required (during project phase).
This role may be for you if you have:
- Knowledge of cGMP manufacturing environment and familiarity with packaging and labeling 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 with parenteral fill/finish operations preferred.
- Previous experience providing technical support preferred.
- Experience with operating and qualifying equipment with high levels of automation is a plus.
- Experience with serialization and serialization systems preferred.
In order to be considered for this position, you must hold a BS in engineering with
- Engineer: 2+ years industry experience
- Sr. Engineer: 5+ years industry experience
- May consider equivalent combination of education and experience. 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 culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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)