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# Analytical Technology & Operations Specialist

- **Company:** Regeneron
- **Location:** Saratoga Springs, NY, United States
- **Experience:** Starter
- **Salary:** $62,355.0 - $131,300.0
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Laboratory Information Management Systems, Systems Integration, GXP
- **Published:** November 5, 2026
- **Apply:** https://www.techcareers.com/job.asp?id=3496636647&tx=JR4337FFP&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54

## About the Role

* BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
 * Assoc Analytical Technology & Operations Specialist: 0-2+ years of relevant experience
 * Analytical Technology & Operations Specialist: 2+ years of relevant experience
 * Sr. Analytical Technology & Operations Specialist: 5+ years of relevant experience
 * Level will be determined based on 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
 * Exposure to laboratory system integration CDS, LIMS, instrument interfacing, or networked data acquisition is preferred
 * Exposure to a laboratory build, relocation, fit-out, or instrument implementation project is preferred

## Description

* Gather and document inputs to the assay-to-space model for the assigned area - equipment lists, footprint measurements, bench linear feet
 * Support development of User Requirement Specification content by documenting equipment and network/instrument integration details; escalate integration decisions
 * Help maintain integration documentation for laboratory systems connecting to the lab bus, flagging any data integrity or control gaps
 * Document material, sample, and personnel flow for the assigned area - 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 pre-defined acceptance criteria testing for lab critical functionality
 * Support LIMS configuration and laboratory digital integration tasks
 * Assist in maintaining integration requirement documentation for lab bus-connected systems, escalating any design-versus-installation discrepancies
 * Draft and revise SOPs for the assigned space - 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 - triaging routine issues and helping execute change control and corrective actions, escalating complex or ambiguous issues to the Senior Specialist