Analytical Tech & QC Operations Specialist

Regeneron Pharmaceuticals, Inc.; City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Saratoga Springs is hiring multiple Analytical Technology & Operations Specialists to join the Quality Control team at our new automated drug substance facility.

The role spans the lifecycle of QC labs, including IQ/OQ/PQ, LIMS integration, and data integrity compliance. The position supports lab workflows, equipment, and data flow, partnering with QA, Engineering, and IT to minimize disruption and ensure cGMP/ALCOA+ adherence.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences required; may substitute relevant experience.
• 0-2+ years for Associate level; 2+ years for Specialist; 5+ years for Senior level.

Responsibilities

• Gather and document inputs to the assay-to-space model: equipment lists, footprint measurements, bench linear feet.
• Document equipment and network/instrument integration details; elevate integration decisions.
• Maintain integration documentation for laboratory systems connecting to the lab bus; flag data integrity gaps.
• Document material, sample, and personnel flow from receipt to waste; per approved process maps.
• Support data integrity risk assessments by collecting evidence and organizing findings for review.
• Prepare materials and impact docs for design reviews and value-engineering changes.
• Coordinate day-to-day logistics for instrument delivery, installation, and FAT/SAT against first test date.
• Execute qualification protocols and acceptance criteria testing for lab functionality.
• Support LIMS configuration and laboratory digital integration tasks.
• Draft and revise SOPs for the assigned space: access, sample handling, instrument operation, waste, etc.
• Assist in dry runs of the sample-to-result path and engineering runs.
• Provide post-hand-over support to site QC testing team and escalate complex issues.

Skills

Data integrity

Lab workflow

GxP familiarity

Project coordination

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

LIMS

CDS

instrument interfacing

networked data acquisition

Job description

Regeneron Pharmaceuticals, Inc. in Saratoga Springs is hiring multiple Analytical Technology & Operations Specialists to join the Quality Control team at our new automated drug substance facility.

The role spans the lifecycle of QC labs, including IQ/OQ/PQ, LIMS integration, and data integrity compliance. The position supports lab workflows, equipment, and data flow, partnering with QA, Engineering, and IT to minimize disruption and ensure cGMP/ALCOA+ adherence.