Analytical Technology & Operations Specialist

Regeneron Pharmaceuticals • Saratoga Springs, UT

4d • $62,355 - $131,300 • Onsite

About The Position

Regeneron is hiring multiple Quality Analytical Technology & Operations Specialists for its Quality Control team at a new, highly automated drug substance manufacturing facility in Saratoga Springs. The role supports the technical and operational lifecycle of QC laboratories, including new lab builds, relocations, technology implementation, and capability upgrades. The Specialist develops an understanding of laboratory workflows, equipment, and sample and data flows to identify and scope improvements. The role executes design and change-support tasks, documents requirements, and supports installation, qualification (IQ/OQ/PQ), computerized system validation, SOP development, and analyst training. In partnership with lab leadership, QA, Engineering, and IT, the Specialist helps minimize disruption to testing, applies cGMP and ALCOA+ principles, and escalates compliance concerns through quality channels.

The position is based in Rensselaer, New York, with a first-shift schedule of Monday through Friday, 8:00 a.m. to 4:30 p.m., and requires 50% domestic travel. The position may be filled at the Associate, Specialist, or Senior Specialist level, with level determined by experience.

Requirements

• Bachelor of Science or Bachelor of Arts in Engineering, Chemistry, or Life Sciences; relevant experience may substitute for education.
• Relevant experience by level: Associate Analytical Technology & Operations Specialist, 0–2+ years; Analytical Technology & Operations Specialist, 2+ years; Senior Analytical Technology & Operations Specialist, 5+ years. Level is determined based on experience.
• Familiarity with data integrity principles (ALCOA+), 21 CFR Part 11, Annex 11, and GxP requirements, with developing ability to apply them under guidance.

Nice To Haves

• Exposure to laboratory system integration, including CDS, LIMS, instrument interfacing, or networked data acquisition.
• Exposure to a laboratory build, relocation, fit-out, or instrument implementation project.

Responsibilities

• Gather and document inputs to the assay-to-space model for the assigned area, including equipment lists, footprint measurements, and bench linear feet.
• Support development of User Requirement Specification content by documenting equipment and network/instrument integration details, and escalate integration decisions.
• Maintain integration documentation for laboratory systems connecting to the lab bus and flag data integrity or control gaps.
• Document material, sample, and personnel flows for the assigned area, from receipt through login, preparation, analysis, retain, and waste, based on approved process maps.
• Support data integrity risk and gap assessments by collecting evidence, completing checklists, and organizing findings for Senior Specialist review.
• Prepare supporting materials and impact documentation for design reviews and proposed value-engineering changes.
• Coordinate day-to-day logistics for instrument delivery, installation, and FAT/SAT activities against the first test-date schedule.
• Execute qualification protocols and predefined acceptance-criteria testing for critical laboratory functionality.
• Support LIMS configuration and laboratory digital integration tasks.
• Assist in maintaining integration requirement documentation for lab bus-connected systems and escalate design-versus-installation discrepancies.
• Draft and revise SOPs for the assigned space, covering access and gowning, sample receipt and handling, instrument operation, cleaning and sanitization, waste, cold chain, and retain management.
• Participate in and help execute sample-to-result dry runs and support engineering runs for the assigned area.
• Provide day-to-day post-handover support to the site QC testing team by triaging routine issues and helping execute change control and corrective actions; escalate complex or ambiguous issues to the Senior Specialist.

Benefits

• Annual bonuses or other incentive plans may be included, depending on country and role.
• Equity awards may be included, depending on country and role.
• Pension or retirement benefits may be included, depending on country and role.
• 401(k) company match may be included, depending on country and role.
• Health and wellness programs may be included, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be included, depending on country and role.
• Paid time off may be included, depending on country and role.
• Family support benefits may be included, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level