Senior Process Controls & Validation Lead (cGMP)

Regeneron Pharmaceuticals, Inc (USA); New York (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Process Controls & Validation Engineer to lead cGMP validation efforts and develop robust process control strategies from transfer through lifecycle management.

The role requires translating ambiguous problems into actionable plans, collaborating with Manufacturing, Quality, and Regulatory teams, and authoring protocols and regulatory documents with emphasis on ICH guidelines. On-site work in East Greenbush, NY.

Qualifications

• 2+ years of cGMP process validation experience.
• 5+ years for Sr. level, with level determined by experience.
• Experience with process validation, tech transfer and scale up for drug substance.
• BS in Engineering; chemical or biomedical engineering preferred.

Responsibilities

• Leads and provides hands-on support for cGMP process validation (Stage1–3) and lifecycle management.
• Develops and implements process control strategies; supports tech transfer and scale-up.
• Authors protocols, reports, and regulatory documents; supports audits and CMC submissions.
• Collaborates across Manufacturing, Quality, QA, and Regulatory to align lifecycle decisions.

Skills

Process validation experience

Tech transfer experience

Scale-up experience

Cross-functional collaboration

Education

BS in Engineering

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Process Controls & Validation Engineer to lead cGMP validation efforts and develop robust process control strategies from transfer through lifecycle management.

The role requires translating ambiguous problems into actionable plans, collaborating with Manufacturing, Quality, and Regulatory teams, and authoring protocols and regulatory documents with emphasis on ICH guidelines. On-site work in East Greenbush, NY.