Principal System Administrator - LIMS at Astellas Pharma in Westborough, MA

Job description

Principal System Administrator - LIMS About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Purpose & Scope The Principal System Administrator defines requirements for implementation and ongoing operation of validated digital systems and serves as the primary interface between Operations and IT. The role supports user and role management, master data and system configuration for platforms including LIMS and electronic batch record applications, while supporting site data integrity and 21 CFR Part 11 compliance for manufacturing and laboratory equipment. Role and Responsibilities Develop and maintain system configuration documentation and plans for new products, equipment, and workflows, and provide first-line troubleshooting support to users. Manage systems in a validated environment and develop policies and procedures supporting compliance requirements. Partner with end users to develop user requirements and configuration documents and coordinate vendor installation and operational qualification activities. Develop, revise, and review SOPs, protocols, reports, and other controlled documents supporting equipment, platforms, and computerized systems. Provide computerized system training, administer system access, support compliance with applicable cGMP regulations and SOPs, and support internal and external audits. Manage system updates, change controls, maintenance activities, and associated operational documentation. Troubleshoot issues, solve problems, and support investigations and deviations involving software systems. Create and manage master data supporting existing and new system functionality. Collect and report system and compliance metrics. Maintain the integrity and accuracy of documentation and assess compliance with protocols, SOPs, company policies, and applicable regulations. Required Qualifications B.S. degree in biological sciences, cell biology, chemistry, or a related field with 7+ years of relevant experience, or M.S. degree with 5+ years of relevant experience working with analytical computerized systems. Experience implementing and managing LIMS and translating laboratory user requirements into IT implementations. Hands-on laboratory experience with a variety of analytical computerized systems. Expertise in regulations governing data integrity and computerized systems. Experience qualifying analytical equipment, including equipment with computerized systems. Experience with electronic document management systems. Strong knowledge of GMP, SOPs, quality control processes, quality systems, and regulatory requirements. Experience with Windows operating systems, domains, networks, and basic computing infrastructure in laboratory or production environments. Strong interpersonal and collaboration skills within multidisciplinary teams. Good to excellent technical writing and verbal communication skills. Ability to manage multiple concurrent tasks in a fast-paced team environment. Highly self-motivated and goal oriented, with a demonstrated commitment to quality standards and high-quality data. Preferred Qualifications Hands-on experience implementing and managing Labware LIMS. Experience in a start-up, high-growth, fast-paced work environment. Experience with instrument integration and direct data capture from stand-alone commercial off-the-shelf systems into a LIMS