Principal System Administrator - LIMS

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

Westborough, Massachusetts, United States

Job Description

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.

Location(s)

Westborough , Massachusetts , United States

Requirements

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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions

Our organization is committed to diversity, equal opportunity, and affirmative action. We are an equal opportunity employer. All applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other protected characteristic.