Manager Quality Assurance Validation Job City of Saratoga Springs New York USA,Quality Assurance

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

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

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

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,…