Compliance Specialist, Engineering & Automation

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

• 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

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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, and family support benefits. 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. If you have any questions, please speak with your recruiter.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

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

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most 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, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.