Quality Assurance Validation Specialist

Regeneron Pharmaceuticals; Saratoga Springs (UT); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals in Saratoga Springs, NY is hiring QA Validation Specialists to join our highly automated drug substance facility. You will generate, execute, and review qualification and validation protocols for laboratory equipment (HPLC, GC, balances, spectrophotometers) to ensure regulatory compliance.

Responsibilities include analyzing results, approving deviations and change controls, coordinating with QC, Manufacturing Science, and vendors, and mentoring teammates.

Qualifications

• Experience validating and qualifying laboratory instrumentation in GMP environments.
• Familiarity with HPLC, GC, balances and spectrophotometers.
• Ability to analyze results and determine acceptance against criteria.

Responsibilities

• Generates, executes, and reviews qualification/validation protocols and reports for lab equipment.
• Analyzes testing results and determines acceptability against criteria.
• Investigates problems and recommends changes or improvements.
• Reviews deviation notifications, investigations, and corrective actions.
• Provides secondary support for manufacturing equipment validation.
• Coordinates with QC, Manufacturing Science and external vendors to complete validation tasks.
• Trains and mentors teammates; may oversee contingent workers.
• Manages projects and prepares status reports.

Skills

GMP experience

Lab instrumentation

Validation protocols

Troubleshooting

Education

BS/BA in Engineering, Chemistry, or Life Sciences

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 Assurance (QA) Validation Specialists to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position validates and qualifies laboratory and analytical equipment in accordance with regulatory requirements, with secondary support for manufacturing equipment and utility validation in a highly automated, digitally integrated biologics environment.

When & where:

• Location:
  • Initial: Rensselaer, New York, United States
  • Permanent: Saratoga Springs, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
  • Other requirements: Occasional flexibility may be requested for on-call schedule/weekend work

Discover your role

• Generates, executes, and/or reviews master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment (e.g., HPLC, GC, balances, spectrophotometers, incubators) for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
• Investigates and troubleshoots problems which occur with laboratory equipment and determines solutions or recommendations for changes and/or improvements
• Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions
• Reviews, edits, and approves change controls, SOPs, reports, and other documentation
• Provides secondary support for qualification of manufacturing equipment and utilities as needed
• Coordinates with Quality Control, Manufacturing Science, and outside contractors/vendors, including Automation and Computer Systems Assurance, to complete validation tasks for a highly automated facility
• Trains, advises and mentors teammate as needed
• May be required to oversee contingent workers
• Manages projects and prepares status reports
• Other duties assigned by management

The environment and physical rhythms of the role:

• Gowning: Full cleanroom attire (examples may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This role requires:

• BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
  • Associate QA Validation Specialist: 0-2+ years of relevant experience
  • QA Validation Specialist: 4+ years of relevant experience
  • Sr. QA Validation Specialist: 6+ years of relevant experience
  • Level will be determined based on experience
• Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is preferred

Does this sound like you? 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.

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 - $128,700.00