Analytical Technology & Operations Specialist

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Analytical Technology & Operations Specialist to join our Quality Control team at our new highly automated drug substance manufacturing facility in Saratoga Springs.   The Analytical Technology & Operations Specialist supports the technical and operational lifecycle of QC laboratories for new lab builds, relocations, new technology implementation, and capability upgrades. This role builds a working understanding of lab workflows, equipment, and sample and data flow to help identify and scope improvements. The QC Lab Specialist executes design and change-support tasks, documents requirements, and supports installation, qualification (IQ/OQ/PQ), computerized system validation, SOPs, and analyst training. Partnering with lab leadership, QA, Engineering, and IT, the Specialist minimizes testing disruption and applies cGMP and ALCOA+ principles, escalating compliance concerns through quality channels.   When & where: • Location: Rensselaer, New York, United States • Work model: 1st, Monday- Friday, 8am-4:30pm • Travel: 50% domestic Discover your role: • 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   This role requires: • 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 interfaci