Compliance Specialist, Engineering & Automation

Regeneron Pharmaceuticals

1d • $62,355 - $128,700 • Onsite

About The Position

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.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level