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.
Write, create, draft, edit, review and maintain documents designed to explain and test automated process control systems and laboratory automation. This individual would also lead other department writers in coordination and completion of group assignments.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Creates and maintains technical writing standards for the Automation unit.
- Writes and creates periodic evaluation reports for automated systems used in commercial manufacturing.
- Performs and documents in writing investigation of manufacturing deviations and anomalies related to automation and software within guidelines specified by SOPs.
- Writes modification/change control documents.
- Creation and review of test plans/test cases and IOQ documents to support Validation.
- Writes, creates, reviews, and maintains system design documentation (such as User Requirement Specifications, Functional Specifications, Software Design Specification, etc), following GAMP 5 guidance.
- Writes, reviews, and maintains department standard operating procedures
- Edit, standardize, or make changes to material prepared by other writers or establishment personnel.
- Coordinates projects and assignments of other department writers.
Education and Experience:
- BS/BA degree in science, engineering, or Technical Writing with a concentration in science, engineering, or applied technology fields required. 5 years of experience with biopharmaceutical equipment or manufacturing, particularly in Quality Review, preferred; will substitute relevant experience for educational requirement.
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.
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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