Associate Manager Engineering and Automation Compliance

Rensselaer, NY, United States
Apr 16, 2019
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, 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: The position provides oversight for all aspects of cGMP compliance for
Engineering &Automation Department.

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

• Ensures cGMP compliance for the Engineering &Automation Department globally

• Oversees the work of all Technical Writers and Compliance Specialists.

• Provide primary support for all audits and inspections.

• Leads development and review of departmental policies and procedures.

• Oversees and administers Periodic Evaluation Reporting (PER) program for all
automation systems.

• Acts as a liaison to quality and regulatory groups to address any compliance issues.

• Provides tracking and trending for all quality system activities NOES, PMs, PERs, etc..

• Specify and coordinate and training, OJT and SOP, for Automation, Engineering and
contracted personnel.

• Provides support and assistance to department members for the initiation, review,
submission, administration of documents such as Change Controls, NOE's, DNF's,
impact statements and corrective action plans.
Education and Experience:

• Requires AAS in an engineering or scientific related field (BA/BS preferred)
with 5+ years of related experience along with 3+years experience working in a
cGMP environment or in the operation of an 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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.