Validation Specialist II-IV

Organization: 
Regeneron
Job Location: 
Rensselaer, NY
Job Description: 

If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

Summary:
Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
- 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 control and SOPs
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Reviews, edits and approves HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department
- Trains/advises less experienced Specialists and Technicians.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation within Regeneron SOPs.
- Manages projects and prepares status reports.

Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the field preferred; may substitute relevant experience for education.
- Should be experienced in one of the following: Assay Validation, Process Validation,
(API or Drug product), Equipment Qualification, Utility qualification cleaning and steaming validation, or shipping qualification.

We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com

ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

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