Compliance Specialist, Engineering & Automation Regeneron - 3.6 Troy, NY Job Details $62,355 - $128,700 a year 23 hours ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications Quality control corrective actions Equipment service recordkeeping Laboratory procedures Performance improvement leadership Quality records maintenance Defect resolution root cause analysis Process audits Laboratory document review Document control experience within pharmaceutical industry Pharmaceutical regulatory compliance Word processing Bachelor of Science Preventive action implementation Spreadsheets Presentations for conferences or internal meetings Technical writing experience within manufacturing Compliance audits & assessments Corrective and preventive actions (CAPA) Mid-level Quality control audit Quality reports Manufacturing standard operating procedures Maintenance activity documentation Database management Bachelor's degree Quality risk management Quality assurance experience within pharmaceutical industry Compliance documentation Operational excellence initiatives Technical writing quality assurance Full Job Description 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. When & where:

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 Let's find out if we're a fit : 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 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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. 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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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