Principal QA Validation Specialist

Location
Tarrytown, NY, United States
Posted
Jul 11, 2019
Ref
16916BR
Required Education
Masters Degree/MBA
Position Type
Full time
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: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

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

• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

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

• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

• Reviews, edits and approves change controls, SOPs, reports and other documentation

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

• Collaborates with functional departments to resolve issues.

• Trains/advises less experienced Specialists.

• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.

• Manage and drives projects and prepares status reports.

• May present at both internal and external (regulatory) audits

• Stays current with industry trends, regulatory requirement updates, and communicating same to team

• May manage full time employees and/or contingent workers.

• Performs other duties assigned by Management.

• Some travel may be required.

Education and Experience:

• BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field required

• Or equivalent combination of education and experience

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.