Assoc Fill/Finish Engineer

Regeneron Pharmaceuticals Inc.; New York (NY); Sur place; USD 62 000 - 92 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Equity awards

Health benefits

Résumé du poste

Regeneron Pharmaceuticals Inc. in New York seeks a Fill/Finish MFG Engineer to serve as SME for formulation, aseptic filling, visual inspection, assembly, and packaging.

You will support equipment design and process development, contribute to tech transfer during start-up and routine manufacturing, and assist validation and training. The role requires collaboration across Engineering, Validation, QA, and Regulatory teams; travel up to 30% domestically or internationally.

Qualifications

• Knowledge of cGMP manufacturing environment and aseptic fill/finish processes.
• Strong interpersonal and problem-solving skills in cross-functional teams.
• Experience with technology transfer and validation activities.

Responsabilités

• Act as technical SME for assigned fill/finish equipment.
• Lead tech transfer studies and continuous improvement initiatives.
• Support equipment design, installation, and qualification.
• Travel up to 30% domestically and internationally.

Connaissances

cGMP manufacturing

Aseptic filling

Process development

Tech transfer

Equipment validation

Cross-functional collaboration

Formation

BS in engineering

MS in engineering

Outils

Automation equipment

Serialization systems

Lyophilization

Description du poste

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.

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 accommodation would impose undue hardship.

Salary and Benefits

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

On-site Expectations

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Salary Range (annually)

$62,355.00 - $92,400.00