Analytical Technology & Operations Specialist

Regeneron Pharmaceuticals; Saratoga Springs (UT); Vor Ort; USD 62.000 - 131.000; Vollzeit

Benefits dieser Stelle

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Zusammenfassung

Regeneron Pharmaceuticals in Saratoga Springs, NY is hiring multiple Quality Analytical Technology & Operations Specialists to join the Quality Control team at our new highly automated drug substance manufacturing facility. This role supports IQ/OQ/PQ, LIMS configuration, and lab system integrations to ensure data integrity and compliant operations.

Responsibilities include documenting workflows, coordinating instrument delivery and testing, drafting SOPs, and assisting in change control while

Qualifikationen

• Requires familiarity with ALCOA+ data integrity, 21 CFR Part 11, Annex 11, and GxP.
• Experience with laboratory data systems and instrument interfaces is preferred.
• Ability to document requirements, SOPs, and change controls with precision.

Aufgaben

• Gather inputs for assay-to-space model, equipment lists, and footprints.
• Support User Requirement Specification content and integration decisions.
• Maintain lab system integration documentation and flag data gaps.
• Document material, sample, and personnel flow from receipt to retention and waste.
• Assist with data integrity risk assessments and organize findings for review.
• Prepare materials for design reviews and value-engineering changes.
• Coordinate instrument delivery, installation, and FAT/SAT activities.
• Execute qualification protocols and acceptance testing for lab functionality.
• Support LIMS configuration and lab bus integration tasks.
• Draft SOPs for the assigned space including sample handling and waste management.
• Assist in dry runs of sample-to-result path and engineering runs.
• Provide post-handover support to site QC testing and participate in change control.

Kenntnisse

Data integrity ALCOA+

GxP knowledge

Lab system interfacing

Documentation

Ausbildung

BS/BA in Engineering, Chemistry, Life Sciences

Tools

LIMS

CDS

Instrument interfacing

Jobbeschreibung

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; elevate 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 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.

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


• 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. If you have any questions, please speak with your recruiter.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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