Principal Automation Systems Administrator - Validation
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Automation Systems Administrator to join our IOPS team, providing technical leadership in the configuration and administration of automated and computerized systems, servers, and network infrastructure across our manufacturing and laboratory operations. In this role, you will serve as the technical SME bridging Automation and the business — driving validation, continuous improvement, and strategic vendor partnerships — while collaborating with Engineering, Quality, IT, and cross-functional teams across the organization. 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
- Principal Automation Systems Administrator: 8+ years of relevant experience
- Staff Automation Systems Administrator: 10+ 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 control, monitoring, and product release testing systems including design and installation
- Advanced experience troubleshooting network infrastructure and server-based systems
- Current knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods
- Strong project management capabilities with the ability to lead changing priorities and make timely decisions across multiple departments and workstreams
Responsibilities
- Develop system hardware and software specifications, code, and networking configurations and standards to meet cGMP and procedural requirements across IOPS
- Provide advanced technical automation support, troubleshooting, and investigations in accordance with established SOPs, GAMP 5 guidelines, and departmental practices
- Lead system SAT/FAT, validation, qualification, and improvement efforts; manage small to large interdepartmental and global projects related to corrective action, software and hardware improvement, and new equipment or infrastructure
- Initiate, author, and review Software Lifecycle Documentation, SOPs, Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and corrective and preventive action plans
- Act as technical liaison between Automation and the business, independently identifying alternative solutions to ambiguous problems and driving continuous improvement in processes, procedures, and architecture standards
- Support selection and assessment of strategic automation partners and vendors; manage vendor relationships and deliverables in alignment with regulatory and business requirements
- Provide training and mentoring to Engineering, Automation, and external departments; may supervise or mentor direct reports and contractors within the department
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
Principal
