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# Compliance Specialist, Engineering & Automation

- **Company:** Regeneron
- **Location:** Troy, NY, United States
- **Experience:** Starter
- **Salary:** $62,355.0 - $128,700.0
- **Contract:** Permanent contract
- **Skills:** Spreadsheets, Databases, GXP
- **Published:** August 6, 2026
- **Apply:** https://www.biospace.com/logon?PipelinedPage=%2Fjob%2F3066053%2Fcompliance-specialist-engineering-and-automation%3FAction%3DContinueJobApplication%23application-form

## About the Role

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

## Description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Were 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., * 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


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