Project Manager Software Validation

Location
Rensselaer, New York, US
Posted
Aug 12, 2018
Ref
12966BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: This position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a compliant validation process for quality information technology systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Analyzes the results of testing and determines the acceptability of results against predetermined criteria.

• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.

• Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Participates in regulatory audits and communicates companies computer validation policies.

• Assesses companies computer systems and identifies any potential Part 11 or Annex 11 gaps.

• Manages projects and prepares status reports.

• May supervise, lead, or manage lower-level personnel.

• Trains /advises less experienced Specialists and Technicians.
Education and Experience:

• Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of computers and biotechnology; will substitute relevant experience for education.

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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.