Compliance Specialist, Engineering & Automation

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 129,000; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Compliance Specialist in Troy, NY. The role focuses on cGMP and procedural compliance for Engineering & Automation, supporting documentation, change controls and CAPAs, and interacting with Quality/Regulatory teams.

On-site, Monday–Friday, with opportunities to present to leadership and regulators. Qualifications include a Bachelor’s degree in life sciences or engineering and 2+ years in a related role.

Qualifications

• Requires a B.S. in life sciences, engineering or related field, or equivalent.
• Knowledge of cGMP biotech/pharma operations and regulatory guidance.
• Ability to manage multiple documents and audit readiness.

Responsibilities

• Maintain up-to-date knowledge of cGMPs and industry guidance and evaluate practices.
• Maintain and review documentation, change controls, investigations and CAPAs.
• Serve as liaison between Engineering & Automation and Quality/Regulatory groups.
• Identify improvement opportunities and support related initiatives.
• Coordinate audits, respond to findings, and track trends across QA and regulatory audits.
• Present to senior management and regulatory agencies; communicate clearly in writing.

Skills

cGMP knowledge

Regulatory liaison

Documentation management

Education

Bachelor's degree in life sciences or engineering

Job description

About Regeneron

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re looking for a Compliance Specialist focusing on engineering and automation. This position ensures and supports cGMP and procedural compliance for our Technical Operations Engineering & Automation Department. This includes conducting evaluations against documents and providing guidance to others on a variety of cGMP work. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location & Work model

Location: Troy, New York, United States

Work model: Monday-Friday, 8am-4:30pm

What you’ll do

• Maintain up-to-date knowledge of cGMPs and Biotech/Pharmaceutical industry guidance (including emerging draft GxP guidance), and evaluate department practices against these standards
• Support the authorship, review, and follow-through of department documentation and records, including change controls, investigations, root cause analyses, risk assessments, impact statements, CAPAs, SOPs/work instructions/job aids, periodic evaluation reports, logbooks, maintenance records/work orders, lifecycle documents, and policies
• Serve as liaison between Engineering & Automation and Quality/Regulatory groups to identify and resolve compliance issues
• Identify continuous improvement opportunities and support or lead related initiatives
• Support audit/inspection coordination, author responses, and track/trend results across department quality, compliance, and regulatory audits/inspections
• Maintain strong knowledge of cGMP biotech/pharma manufacturing operations and laboratory testing, regulatory and quality requirements/guidance, and root cause and risk management techniques, procedures, and documentation methods
• Manage multiple tasks and meet deadlines
• Present to large groups, including senior management and regulatory agencies
• Communicate clearly and professionally in writing and interpersonal interactions
• Apply working knowledge of word processing, spreadsheet, presentation, and database management software

Experience Levels

• Associate Compliance Specialist: 0-2+ years of experience
• Compliance Specialist: 2+ years of experience
• Senior Compliance Specialist: 5+ years of experience
• Level will be determined based on experience

Requirements

Requires B.S in life sciences, engineering or related field; or equivalent combination of education and experience.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

Salary

Salary Range (annually) $62,355.00 - $128,700.00

Equal Opportunity

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

On-site Requirements

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

Company Overview

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

For other locations, additional information will be provided during the recruitment process.