Fill/Finish MFG Engineer
We are currently looking to fill a Fill/Finish Manufacturing Engineer position. This position will serve as a specialist for formulation, aseptic filling and visual inspection equipment and processes 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 targeted equipment, processes and operators.
In this role, a typical day might include the following:
• Acting as the Filling process specialist responsible for the following processes: formulation, aseptic filling, visual inspection and in-process CCIT
• Serving as the primary interface between operations and Engineering, Combination Products, Validation and Quality Assurance to support tech transfer studies / tech transfer, investigations, innovative technology adoption and continuous improvement
• Supporting equipment / new technology design, install and qualification
• Leading material and component selection and approval for tubing, filters and primary container components
• Providing the technical content of the training program for operations and operations support teams as well as drafting various SOP's for formulation, filling and the visual inspection program and equipment operation
• Driving innovation in formulation, filling and visual inspection equipment and techniques by staying on top of latest technological advancements
• Collaborating with other departments such as Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control
• Recommending capital expenditures and aids in the realization of capital projects
• Representing manufacturing during regulatory and client audits
• Tracking relevant technical and business process metrics to ensure operations are performing efficiently
• Reviewing Standard Operating Procedures, specifications, regulatory filing or other controlled documents as needed
This role may be for you if you:
• Enjoy travel approximately 30 % 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 proven ingenuity, creativity and resourcefulness
To be considered for this role you must hold a Bachelor's degree in Engineering for Associate Engineer level, 2+ years of related experience for Engineer level, 5+ years for Senior Engineer level. Technology transfer and equipment / process validation experience of aseptic, parenteral fill finish operations preferred. Previous experience providing technical support is also preferred. Level is determined based on qualifications relevant to the role.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.