Associate Investigation Specialist - Engineering (New Grad/Entry Level)
Company: Regeneron Pharmaceuticals, Inc.
Posted on: November 19, 2022
We are currently looking to fill an Investigation Specialist
(Engineering & Automation) position. This position ensures and
supports cGMP compliance for the Engineering & Automation
Department.In this role, a typical day might include the
- Leads, authors, and supports sophisticated investigations and
root cause analysis for equipment, control system, lab system, and
- 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
- 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
- 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
- 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,
- 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
- 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+ yearsMay 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 comprehensive
benefits including health and wellness programs, fitness centers
and equity awards, annual bonuses, and paid time off for eligible
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 parental 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.The salary ranges provided are shown in accordance with U.S.
law and apply to U.S. based positions, where the hired candidate
will be located in the U.S. If you are outside the U.S, please
speak with your recruiter about salaries and benefits in your
location.Salary Range (annually) $55,700.00 - $121,300.00
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Associate Investigation Specialist - Engineering (New Grad/Entry Level), Engineering , Troy, New York
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