Senior LIMS & Validation Systems Lead

Astellas; Westborough (MA); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) match

Bonuses program

Paid time off

Job summary

Astellas is seeking a Principal System Administrator for its Westborough, MA site to lead validated digital systems in manufacturing and QC. You will manage LIMS and electronic batch record systems, ensuring data integrity and regulatory compliance while partnering with IT and operations.

The role requires building documentation, training, vendor coordination, and supporting internal audits in a fast-paced cGMP environment. On-site work is essential at the Westborough facility.

Qualifications

• BS in biological sciences, chemistry, or related field with 7+ years of relevant experience, or MS with 5+ years in analytical computerized systems.
• Experience implementing and managing LIMS and translating laboratory user requirements into IT implementations.
• Hands-on laboratory experience with analytical computerized systems.
• Expertise in regulations governing data integrity and computerized systems.
• Experience qualifying analytical equipment with computerized systems.
• Experience with electronic document management systems.
• Strong knowledge of GMP, SOPs, quality control processes and regulatory requirements.
• Experience with Windows operating systems, domains, networks, and basic computing infrastructure.

Responsibilities

• Develop and maintain system configuration documentation for new products, equipment, and workflows and provide first-line troubleshooting for users.
• Manage systems in a validated environment and develop policies supporting compliance requirements.
• Coordinate vendor installation and qualification activities with end users.
• Develop, revise, and review SOPs, protocols, reports, and other controlled documents for equipment and systems.
• Provide computerized system training, administer system access, and support audits and regulatory compliance.
• Manage system updates, change controls, maintenance activities and related documentation.
• Troubleshoot issues and support investigations and deviations involving software systems.
• Create and manage master data supporting system functionality.
• Collect and report system and compliance metrics.
• Maintain integrity and accuracy of documentation and assess compliance with protocols and policies.

Skills

LIMS implementation

Labware LIMS experience

Data integrity regulations

Analytical computerized systems

Windows OS & networks

Cross-functional collaboration

Technical writing

Education

BS in biological sciences / chemistry

MS in related field

Tools

Labware LIMS

Instrument integration

Job description

Astellas is seeking a Principal System Administrator for its Westborough, MA site to lead validated digital systems in manufacturing and QC. You will manage LIMS and electronic batch record systems, ensuring data integrity and regulatory compliance while partnering with IT and operations.

The role requires building documentation, training, vendor coordination, and supporting internal audits in a fast-paced cGMP environment. On-site work is essential at the Westborough facility.