Process Specialist - Manufacturing
Listed on 2026-07-22
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Manufacturing / Production
Quality Engineering, Manufacturing Engineer, Validation Engineer, Manufacturing & Industrial Operations
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 Manufacturing Process Specialist (Associate through Senior level) to join our IOPS team, providing technical support across our manufacturing processes and playing a key role in the implementation and transfer of our production programs. In this role, you will resolve process challenges, support manufacturing personnel on the floor, and drive continuous improvement — while collaborating with Process Sciences, Engineering, Maintenance, Quality, Regulatory, and Facilities teams.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Location:
East Greenbush, New York, United States
Work model:
Monday - Friday 8am - 4:30pm
Liaise with process science and technology transfer teams on the transfer and startup of manufacturing processes; serve as a key technical contributor to manufacturing records, batch sheets, and procedures
Provide technical input to resolve process problems on and off the production floor; support manufacturing personnel in building technical knowledge of critical process steps
Write and review SOPs and other controlled documents; modify process method files through the quality system in alignment with change control requirements
Support CAPA implementation for process-related improvements and contribute to investigations into process variances in accordance with site procedures
Partner cross-functionally with Maintenance, Process Sciences, Engineering, Facilities, Process Development, Regulatory, Quality Assurance, and Quality Control to resolve process issues and implement improvements
Support Right First Time (RFT) programs on the floor and implement continuous improvement initiatives across manufacturing operations
Represent Manufacturing during regulatory and client audits; uphold the highest safety standards and support safety improvements requiring technical input
Experience in a cGMP manufacturing environment with familiarity with drug substance or drug product manufacturing processes preferred
This Role Requires:BS in Life Sciences or a related field
Associate Specialist: 0–2 years of relevant cGMP manufacturing, engineering, or scientific experience
Specialist: 2+ years of relevant cGMP manufacturing, engineering, or scientific experience
Senior Specialist: 5+ years of relevant cGMP manufacturing, engineering, or scientific experience
May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role
Gowning:
Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
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