We are currently looking to fill a Principal Fill/Finish Manufacturing Engineer position. 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.
In this role, a typical day might include the following:
Acting as technical SME for assigned equipment and areas in fill/finish manufacturing facility
Collaborate with other departments such as Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control.
Leads tech transfer/tech transfer studies, investigations, innovative technology adoption and continuous improvement initiatives.
Develops strategy for cycle development and other studies on manufacturing equipment as defined by end user needs.
Stays abreast of latest technologies and industry benchmarks to make recommendations to senior management.
Designs and drives cycle development and other studies on manufacturing equipment as defined by end user needs.
Supports equipment / new technology design, install, and qualification.
Leads change parts and recipe creation for new product introduction.
Leads material and component selection, design, and approval. Works with internal partners and external vendors to craft, source, and implement materials.
Leads 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 paying attention to 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 optimally and efficiently.
May lead and/or manage others
Partners cross functionally to establish standards for formulation and filling.
Identifies and solves customer problems with minimal direction
Negotiates with external parties on behalf of IOPS
Mentors others on effective problem solving
Uses technical expertise to influence decision making to a non-technical audience
This role may be for you if you:
Enjoy travel approximately 15% of the time (domestic and international)
Have knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling and visual inspection of liquid and lyophilized injectable products
Are experienced with operating and qualifying equipment with high levels of automation
Demonstrate strong interpersonal, cross- cultural, communication, and problem-solving skills
Exhibit confidence, have a high emotional IQ, and tried ingenuity, creativity and resourcefulness
To be considered for the Principal Fill/Finish Manufacturing Engineer role you must hold a BS/BA in Engineering with 8 years industry experience or equivalent combination of education and experience.
To be considered for the Staff Fill/Finish Manufacturing Engineer role you must hold a BS/BA in Engineering with 10 years industry experience or equivalent combination of education and experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)