Sr Staff Fill/Finish MFG Engineer

Regeneron; United States; Sur place; USD 140 000 - 170 000; Plein temps

Résumé du poste

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

You will support equipment design, process development, and tech transfer for Regeneron internal operations. The role involves hands-on problem solving during technology transfer, cGMP start-up, and routine manufacturing, with 30% travel.

Qualifications

• BS/BA in Engineering with 12 years of industry experience
• Knowledge of cGMP manufacturing environment
• Experience with formulation, aseptic filling, visual inspection, labeling and packaging

Responsabilités

• Interfaces with Engineering, Validation, DP Process Development, Regulatory, QA and Quality Control.
• Leads tech transfer studies, investigations, and continuous improvement initiatives.
• Develops strategy for cycle development and other studies on manufacturing equipment.
• Stays abreast of latest technologies and industry benchmarks to make recommendations to senior management.
• Designs and executes cycle development and other studies on manufacturing equipment as defined by end user needs.
• Supports equipment design, install, and qualification.
• Leads material and component selection with internal stakeholders and external vendors.
• Reviews SOPs and regulatory filings as needed.
• Supports SOP development and revision for assigned equipment and process operations.
• Recommends capital expenditures and aids in capital projects realization.
• May represent manufacturing during regulatory and client audits.
• Tracks and trends relevant technical and business process metrics.
• May lead and/or manage others.
• Partners cross functionally to establish standards for formulation and filling.
• Identifies and solves customer problems with minimal supervision.
• negotiates with external parties on behalf of IOPS

Connaissances

Formulation

Aseptic filling

Visual inspection

Packaging & labeling

cGMP knowledge

Formation

BS/BA in Engineering

Description du poste

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr Staff Fill/Finish MFG Engineer who 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.

When & where:

Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8:00am-4:30pm
Travel: 30% international & domestic

Discover your roles:

• 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.
• 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 executes cycle development and other studies on manufacturing equipment as defined by end user needs.
• Supports equipment / new technology design, install, and qualification.
• Leads material and component selection, design, and approval. Works with internal stakeholders and external vendors to design, 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.
• 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.
• May lead and/or manage others.
• Partners cross functionally to establish standards for formulation and filling.
• Identifies and solves customer problems with minimal supervision.
• Negotiates with external parties on behalf of IOPS

This role requires:

Requires a BS/BA in Engineering with 12 years industry experience or equivalent combination of education and experience.

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.

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.

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.