Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Coordinates/supervises automated system lifecycle development and maintenance activities for process control and computerized systems.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Develops and revises methods, record keeping, policies and procedures for automated systems and processes in compliance with foreign and domestic government agency regulation and guidance.
* Directs and participates in investigation and resolution of GMP computerized system software and hardware issues.
* Insures GMP computerized systems and software are maintained in a validated state.
* Implements change control following established procedures.
* Directs and manages projects impacting system administration and SLC.
* Coordinates maintenance and development activities with IT relating to validated servers for GMP computerized systems.
* Coordinates maintenance and system administration activities of automation.
* Supports validation of automated systems following SLC design mythology and CSV principles.
* Supervises small team of direct reports.
* Supervises and manages performance of small team of direct reports.
* Performs related duties as assigned.
* Requires a BS/BA in Science/Engineering, computer science or related field and 3 years of relevant experience in pharmaceutical manufacturing setting, or may substitute 5 years of relevant experience in pharmaceutical manufacturing setting for educational requirement.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.