Principal Automation Systems Administrator - Validation

About the role

Join our IOPS team as a Principal Automation Systems Administrator, providing technical leadership in the configuration and administration of automated and computerized systems, servers, and network infrastructure across our manufacturing and laboratory operations.

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
• Principal Automation Systems Administrator: 8+ years of relevant experience
• Staff Automation Systems Administrator: 10+ years of relevant experience