Analytical Technology & Operations Specialist

Regeneron Pharmaceuticals • Saratoga Springs, NY

3d • 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 during new laboratory builds, relocations, technology implementation, and capability upgrades. The Specialist develops an understanding of laboratory workflows, equipment, and sample and data flows to help identify and scope improvements.

The role executes design and change-support tasks, documents requirements, and supports equipment installation, qualification (IQ/OQ/PQ), computerized system validation, SOP development, and analyst training. Working with laboratory leadership, QA, Engineering, and IT, the Specialist helps minimize testing disruption, applies cGMP and ALCOA+ principles, and escalates compliance concerns through quality channels. The role also provides day-to-day post-handover support to the site QC testing team, triaging routine issues and helping with change control and corrective actions while escalating complex or ambiguous issues to the Senior Specialist.

The position is based in Rensselaer, New York. The stated schedule is first shift, Monday through Friday, 8:00 a.m. to 4:30 p.m., with 50% domestic travel. The level is determined based on experience: Associate Specialist requires 0–2+ years of relevant experience, Specialist requires 2+ years, and Senior Specialist requires 5+ years.

Requirements

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may be substituted for education.
• Associate Analytical Technology & Operations Specialist: 0–2+ years of relevant experience.
• Analytical Technology & Operations Specialist: 2+ years of relevant experience.
• Senior Analytical Technology & Operations Specialist: 5+ years of relevant experience.
• Familiarity with data integrity principles (ALCOA+), 21 CFR Part 11, Annex 11, and GxP requirements, with a developing ability to apply them under guidance.

Nice To Haves

• Exposure to laboratory system integration, such as 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, flagging data integrity or control gaps.
• Document material, sample, and personnel flow for the assigned area, from receipt through login, preparation, analysis, retain, and waste, based on approved process maps.
• Support data integrity risk and gap assessment activities by collecting evidence, completing checklists, and organizing findings for the Senior Specialist’s 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.
• Maintain 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 dry runs of the sample-to-result path 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.
• Support installation, qualification, computerized system validation, SOPs, and analyst training.
• Partner with laboratory leadership, QA, Engineering, and IT to minimize testing disruption, apply cGMP and ALCOA+ principles, and escalate compliance concerns through quality channels.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits.

What This Job Offers

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