Senior Automation Systems Administrator - Validation

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Automation Systems Administrator to join our IOPS team, providing expertise in the configuration and administration of automated and computerized system software and firmware across our manufacturing and laboratory operations. In this role, you will ensure systems remain in a compliant and validated state leading projects, driving continuous improvement, and delivering advanced technical support while collaborating with Manufacturing, Quality Control, Facilities, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where:

• Location: Menands, New York, United States
• Work model: Monday - Friday 8am - 4:30pm

Discover your role:

• Configure and maintain cGMP software for process control, monitoring, and testing; manage user access, system security, configuration management, and recipe and method management to meet regulatory requirements
• Determine data backup and archive requirements and configurations to meet defined RTO and RPO targets; design and maintain recovery processes
• Ensure systems remain in a compliant state by processing change control requests including requirement and design specifications, test plans, technical evaluations, and quality risk assessments
• Support and lead system SAT/FAT, validation, and qualification efforts; generate and execute testing and qualification protocols for automated process, monitoring, and testing equipment
• Initiate, author, and review Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and corrective and preventive action plans; lead investigations and root cause analyses for non-compliance issues
• Lead multiple small to medium-sized projects related to corrective action, software performance improvement, and new equipment and software implementation
• Provide advanced technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities in accordance with established SOPs and departmental practices
• Support system integration with existing platforms such as LIMS and Historian; draft, approve, and follow relevant system software SOPs and policies; identify opportunities for continuous improvement in processes, procedures, and architecture standards

• Direct experience in a pharmaceutical or biopharmaceutical manufacturing facility preferred
• Advanced experience configuring and troubleshooting process control, monitoring, and product release testing systems including design and installation
• Expertise in developing Software Lifecycle Documentation, software design documents, technical evaluations, and test plans for cGMP process equipment following GAMP 5 guidelines
• Current knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods

This role requires:

• BS/BA in Science, Engineering, or a related field with 5+ years of relevant experience
• May consider equivalent combination of education and 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) $78,700.00 - $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.