Compliance Specialist (Engineering)

Location
Rensselaer, NY
Posted
Sep 24, 2019
Ref
17697BR
Required Education
Bachelors Degree
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Ensures and supports cGMP compliance for the Rensselaer Tech Ops Engineering Department.
*Level to be determined based on qualifications relevant to the role*
Essential Duties and Responsibilities include, but are not limited to, the following:

• Creates and updates Standard Operating Procedures, Work Instructions, Job Aids, Automated System Design Specifications, and Equipment Specifications.

• Owns change controls on behalf of subject matter experts and interprets testing requirements based on technical documents provided by subject matter expert.

• Leads, authors, and supports investigations and root cause analysis for equipment-related and compliance-related investigations.

• Provides tracking and trending of compliance activities (ex, change controls, investigations, corrective and preventive actions).

• Acts as a liaison between Engineering and Quality/Regulatory groups to address compliance-related items.

• Coordinates and/or assists Engineering Department in preparation of regulatory inspections. Acts as a department liaison during regulatory inspections and coordinates post-inspection activities.

Knowledge, Skills & Abilities: • Strong knowledge of cGMP operations, regulatory, and quality requirements.

• Strong written and oral communication skills.

• Strong knowledge of equipment specification requirements.

• Sets priorities within defined responsibilities with minimal supervision/guidance.

• Ability to review and understand engineering drawings.

• Ability to understand project plans and schedules.

• Working knowledge of word processing, spreadsheet, PowerPoint and database management software

Education and Experience:

• Associate Compliance Specialist - Requires BS or higher in Engineering and 0-2+ years of related experience working in a cGMP environment or in the operation of a regulated industrial facility.

• Compliance Specialist - Requires BS or higher in Engineering and 2+ years of related experience working in a cGMP environment or in the operation of a regulated industrial facility.

• Sr Compliance Specialist - Requires BS or higher in Engineering and 5+ years of related experience working in a cGMP environment or in the operation of a regulated industrial facility.

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, disability status, protected veteran status, or any other characteristic protected by law.
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