About this opportunity
Regeneron Pharmaceuticals, Inc lists this Manager Quality Assurance Validation opportunity in city of saratoga springs, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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, 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
family support benefits
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.
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
#J-18808-Ljbffr
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.