Principal Quality Assurance Validation Specialist

Regeneron Pharmaceuticals; Saratoga Springs (UT); On-site; USD 92,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking QA Validation Specialists for our Saratoga Springs, NY facility. You will validate and qualify laboratory and analytical equipment (HPLC, GC, balances, spectrophotometers, incubators) to GMP standards, with optional leadership responsibilities in the future.

The role entails analyzing results, addressing deviations, and coordinating with QC, Manufacturing Science, and external vendors in a highly automated, digitally integrated environment.

Qualifications

• Experience with laboratory or analytical instrumentation in a GMP environment.
• Previous people leadership/supervisory experience preferred.

Responsibilities

• Generates, executes, and reviews qualification and validation protocols, summaries, and data for lab/analytical equipment.
• Analyzes testing results and determines acceptability against criteria.
• Investigates problems with lab equipment and recommends solutions.
• Reviews deviation notifications, investigations, and corrective actions.
• Reviews change controls, SOPs, reports and other docs.
• Provides secondary support for qualification of manufacturing equipment and utilities.
• Coordinates validation tasks with Quality Control, Manufacturing Science, and external vendors.
• Trains and mentors teammates; may manage staff and contractors.
• Manages projects and prepares status reports.
• Other duties as assigned.

Skills

Laboratory instrumentation GMP

Leadership experience

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. This role may have direct reports in the future.

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 manage full-time employees as well as contractors
• 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
  • Principal QA Validation Specialist: 8+ years of relevant experience
  • Staff QA Validation Specialist: 10+ 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
• Previous people leadership/supervisory experience 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.

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. 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)

$92,200.00 - $176,000.00