Senior Automation Systems Administrator - Validation
About The Position
Build our future together: 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.
Requirements
- BS/BA in Science, Engineering, or a related field with 5+ years of relevant experience
- May consider equivalent combination of education and experience
- 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
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
