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Sr Investigation Specialist (Engineering)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Sep 21, 2022

View more

Discipline
Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

 

We are currently looking to fill a Sr Investigation Specialist (Engineering) position. This position ensures and supports cGMP compliance for the Engineering & Automation Department.

In this role, a typical day might include the following:

  • Leads, authors, and supports sophisticated investigations and root cause analysis for equipment, control system, lab system, and compliance-related events.

  • Owns complex change controls and authors technical documents in support of the change (ex, technical evaluations, test plans).

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

  • Authors complex Periodic Evaluation Reports for automated process equipment, clean utilities, and lab systems.

  • Supports creating and updating Standard Operating Procedures, Work Instructions, Job Aids, Templates, Equipment Specifications, and System Design Specifications (ex, User Requirement Specifications, Functional Specifications, System Design Specifications).

  • Performs compliance review of executed work documented in CMMS (ex, Blue Mountain Regulatory Asset Manager).

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

  • Acts as a liaison between Engineering & Automation and on-site Quality groups to address compliance-related items.

  • Maintain knowledge of current good manufacturing practices (cGMP) and biotech/pharmaceutical industry guidance (ex, ASME BPE, GAMP 5).

  • Identify and implement continuous improvements.

This role may be for you if you:

  • Have advanced knowledge of cGMP operations, regulatory, quality requirements, root cause analysis and risk evaluation.

  • Possess strong written and verbal communication skills.

  • Have working knowledge of equipment specification requirements.

  • Are able to work with minimal supervision/guidance.

  • Can review and understand engineering drawings.

To be considered for this role you must hold a Bachelor’s degree in science or engineering and the following minimum amounts of related experience working in a cGMP environment or in the operation of a regulated industrial facility for each level:

  • Associate Specialist – 0-2+ years

  • Specialist – 2+ years

  • Senior Specialist – 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

#REGNQA

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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