Principal System Administrator - LIMS

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 application.

Location and Working Environment

• This position is based in Westborough, Massachusetts, and requires on-site work in a cGMP-regulated manufacturing facility.
• The role frequently requires extended periods of sitting or standing, use of hands, and regular movement including bending and stooping, with lifting up to 20 pounds.
• Occasional travel to other Astellas manufacturing facilities may be required (0-5%).
• Occasional weekend work as needed to accommodate production schedule.