Automation Compliance Specialist

Organization: 
Regeneron
Job Location: 
Rensallear, 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:
Responsible for the coordination of cGMP compliance for the Rensselaer Tech Ops Automation/Engineering Department.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Facilitates all reviews and revisions of Department related SOP's, plans and policies for each group within the Department.
- Acts as a liaison between Automation/Engineering and onsite quality and regulatory groups to define and address all issues of non-compliance.
- Provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as Change Controls, NOE's, DNF's, impact statements and corrective action plans.
- Participates in investigations and root cause analysis for all department issues of non-compliance.
- Provides tracking and trending for all maintenance related compliance activities i.e NOEs, PMs, and PERs.
- Provide periodic review of department documentation and records such as logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.
- Participate in and obtain results of all department quality and regulatory audits.
- Specify and coordinate and training, OJT and SOP, for Automation, Engineering and contracted personnel.
- Follows current good manufacturing practices (cGMPs).

Education and Experience:
- Requires BA/BS (engineering or scientific related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute AAS degree and relevant experience in lieu of BA/BS degree.

Title level (Associate, Mid-Level, or Sr.) will be determinded based on skills and experience.

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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