Analytical Technology & Operations Specialist

BioSpace; City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron is hiring for an Analytical Technology & Operations Specialist to support QC lab builds, relocations, and automation at a new facility in Saratoga Springs. The role covers IQ/OQ/PQ, LIMS integration, and design documentation, with heavy emphasis on cGMP and ALCOA+ compliance.

You will help maintain lab workflows, support instrument qualification, and collaborate with QA, Engineering, and IT to minimize disruption and ensure data integrity across the lab bus.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience acceptable.
• Experience with lab informatics, data integrity and quality systems.

Responsibilities

• Gather inputs for assay-to-space model and equipment lists.
• Document equipment/network integration details and escalate decisions.
• Maintain integration docs for lab systems and data flow.
• Document sample, material, and personnel flow per approved maps.
• Support data integrity risk assessments and track findings.
• Prepare material for design reviews and change proposals.
• Coordinate instrument delivery, installation, and FAT/SAT.
• Execute qualification protocols and acceptance testing for lab functions.
• Support LIMS configuration and digital lab integration.
• Draft SOPs for space access, gowning, and sample handling.

Skills

GxP knowledge

Data integrity (ALCOA+)

21 CFR Part 11

Process validation

Quality systems collaboration

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

LIMS

CDS

Lab automation

Instrument interfacing

Job description

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; escalating 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 Specialists 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 busconnected 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 educationAssoc 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

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)
$62,355.00 - $131,300.00