Compliance Specialist, Engineering & Automation
Regeneron
August 06, 2026
On-site
Troy, NY
Corporate Functions
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 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.
Qualifications
- Requires B.S. in life sciences, engineering, or related field; or equivalent combination of education and experience.
- Associate Compliance Specialist: 0–2+ years experience.
- Compliance Specialist: 2+ years experience.
- Senior Compliance Specialist: 5+ years experience.
- Level determined based on experience.
- 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 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.
Qualifications
- Requires B.S. in life sciences, engineering, or related field; or equivalent combination of education and experience.
- Associate Compliance Specialist: 0–2+ years experience.
- Compliance Specialist: 2+ years experience.
- Senior Compliance Specialist: 5+ years experience.
- Level determined based on experience.