Assoc Fill/Finish Engineer

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Travel opportunities

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Fill/Finish MFG Engineer to act as an expert for formulation, aseptic filling, visual inspection, assembly, and packaging processes.

The role supports equipment design, process development, validation, and training while partnering with Engineering, Validation, QA, and Regulatory teams. The ideal candidate will lead tech transfer, drive improvements, and manage equipment qualification and change control.

Qualifications

• BS in engineering with 2+ years industry experience or MS with 1+ years.
• Sr. Engineer: BS in engineering with 5+ years industry experience; MS with 4+ years.

Responsibilities

• Acts as technical SME for assigned equipment and areas in fill/finish manufacturing facility.
• Leads tech transfer studies, investigations and continuous improvement initiatives.
• Supports equipment design, install and qualification.
• Drives capital expenditures and capital projects.
• May represent manufacturing during audits.

Skills

cGMP manufacturing

Formulation

Aseptic filling

Visual inspection

Tech transfer

Process validation

Problem solving

Education

BS in engineering

MS in engineering

Job description

Summary

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.

Essential Duties and Responsibilities

• Acts as technical SME for assigned equipment and areas in fill/finish manufacturing facility.
• Interfaces 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.
• Designs and executes cycle 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).
• May lead others

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 5+ years industry experience; MS with 4+ years industry experience or equivalent combination of education and experience.

Knowledge, Skills and Abilities

• 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.
• Experience with serialization and serialization systems is a plus.

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We are committed to building a workplace with an inclusive culture.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such