Principal Automation Systems Administrator - Validation

About the role

Join our IOPS team as a Principal Automation Systems Administrator to drive validation, continuous improvement, and strategic vendor partnerships while collaborating with Engineering, Quality, IT, and cross-functional teams.

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

Requirements

• 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

Qualifications

• BS/BA in Science, Engineering, or a related field
• 8+ years of relevant experience for Principal Automation Systems Administrator
• 10+ years of relevant experience for Staff Automation Systems Administrator

Skills

• Technical expertise in automation systems and network infrastructure
• Strong problem-solving and project management skills
• Excellent communication and collaboration abilities
• Ability to work independently and in a team environment

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.

Pay

$92,200.00 - $150,600.00 annually

Schedule

Monday - Friday 8am - 4:30pm