Associate Project Manager, Software Validation

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 computer system validation (CSV) process for systems which requires formal validation documentation under appropriate regulatory requirements, GAMP guidelines and company manufacturing standards.

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

• Facilitates the planning and coordination of CSV projects.

• Assigns, prioritizes and oversees work of CSV project team members.

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

• 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.

• Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.

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

• Serves in a supporting role during internal and external audits and inspections and communicates company's computer validation policies and procedures.

• Proposes and implements continuous improvement initiatives, including revision of department procedures and work instructions.

• Helps to ensure CSV projects and improvement initiatives are aligned with overall company and QA goals.

• Helps to ensure integrity of department performance metrics and drive initiatives to improve those results.

• Initiates and manages corrective actions resulting from audit or inspection findings or other quality events pertaining to CSV deliverables or activities and determines solutions or recommendations for changes and/or improvements.

Education and Experience:

• Requires BS/BA in Engineering, IT, or Computer Science with 8+ years of related experience within the fields of computers or biotechnology; will substitute relevant experience for education. Experience in a regulated manufacturing environment preferred.

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.
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