Manager Quality Assurance Validation

Regeneron Pharmaceuticals, Inc.; City of Saratoga Springs (NY); Presencial; USD 120.000 - 190.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY is seeking a Manager QA Validation to lead the laboratory and analytical equipment qualification function within a highly automated drug substance facility.

You will drive qualification strategies for HPLC, GC, and analytical systems, and oversee utilities, cleaning/sterilization validation, and related documentation. The role requires 7+ years in QA validation with GMP QC or manufacturing science experience, strong leadership, and proven

Qualificações

• BS/BA in Engineering, Chemistry, Life Sciences or related field; or equivalent combination of education and experience.
• 7+ years in QA validation leadership within GMP QC or manufacturing science environments.
• Experience qualifying laboratory and analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers).
• Strong leadership, budgeting, and regulatory inspection readiness.

Responsabilidades

• Lead laboratory and analytical equipment qualification and validation programs for QC and manufacturing science.
• Oversee qualification strategies for laboratory instrumentation and secondary areas like utilities and cleaning/sterilization validation.
• Develop budgets, contracts, and schedules; defend validation data to FDA and other regulators.
• Coordinate resources and liaise with site leadership to align validation with automation programs.

Conhecimentos

QA leadership

GMP QC

Validation strategy

Budget management

Regulatory inspections

Formação

BS/BA in Engineering, Chemistry, Life Sciences

Ferramentas

HPLC

GC

Spectrophotometers

Analytical software

Descrição da vaga

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're hiring a Manager Quality Assurance (QA) Validation to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position leads the laboratory and analytical equipment validation function. They are responsible for qualification of laboratory and analytical instrumentation supporting quality control (QC) and manufacturing science functions, with secondary oversight of manufacturing equipment, utility qualification, and cleaning/sterilization validation processes. They will participate in and defend validation data during FDA and other regulatory inspections.

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:

• Designs and develops policies related to laboratory and analytical equipment qualification and validation, and secondarily to manufacturing equipment, utility, and process validation, ensuring effective administration and regulatory compliance
• Responsible for all aspects of QA laboratory equipment validation, including review and approval of failure investigations, change controls and associated test plan documentation, SOPs, qualification protocols and summary reports, and relevant Validation Master Plan content
• Leads qualification strategy for laboratory and analytical instrumentation (e.g., HPLC, GC, spectrophotometers, balances, incubators, and software-integrated analytical systems) supporting QC, manufacturing science, and release testing
• Provides secondary oversight of manufacturing equipment and utility qualification and cleaning/sterilization validation programs
• Develops and manages validation budget, contracts, and schedules
• Presents and defends validation data to FDA and other regulatory agencies
• Maintains the validation document and software control system for laboratory equipment and instrumentation qualification records
• Ensures validated state is maintained for laboratory, analytical, and manufacturing equipment used in commercial and clinical operations
• Organizes QA Validation resources assigned to functional areas to meet goals and timelines; coordinates prioritization of activities with laboratory and manufacturing area management
• Partners with the Director, QA Validation & Computer Systems Assurance, and with Quality Control/Manufacturing Science leadership to align laboratory equipment qualification strategy with the site's CSA and automation qualification programs
• Plays a proactive role in developing and applying new approaches and processes to laboratory and equipment validation strategies for a highly automated facility
• Counsels employees on work performance; conducts hiring and separation activities

The environment and physical rhythms of the role:

• Gowning: Full cleanroom attire (Examples may include: including 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
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

This role requires:

• BS/BA in Engineering, Chemistry, Life Sciences or a related field; or equivalent combination of education and experience
• Associate Manager QA Validation: 6+ years of experience
• Manager QA Validation 7+ years of experience
• Level will be determined based on experience
• Previous people leadership/ supervisory experience
• Experience qualifying laboratory and analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP QC or manufacturing science environment
• Experience validating equipment and utilities in a highly automated or greenfield manufacturing environment 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 ve