Role Summary |
We are seeking a skilled and motivated Systems Applications Manager to oversee the configuration, maintenance, and continuous improvement of Laboratory Information Management Systems (LIMS) and other enterprise software applications. This role is critical to ensuring application stability, regulatory compliance, and alignment with business and laboratory needs and workflows. The successful candidate will serve as a cross-functional liaison between IT, lab operations, quality assurance, finance, and the LIMS platform provider while also providing responsive technical support and driving application-related projects. |
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Role Responsibilities |
- Administer and maintain the LIMS and associated laboratory software and interfaces as part of the company’s overall LIMS technology platform strategy.
- Configure LIMS workflows, templates, roles, and permissions in line with operational and compliance needs.
- Integrate LIMS with laboratory instruments, consistent with regulatory guidelines.
- Integrate with the company’s overall Data Management technology platform strategy (e.g., ensuring data integration with ERP platform, and other business applications).
- Conduct system upgrades, patching, and validation activities, ensuring minimal disruption to operations.
- Perform regular system health checks, data integrity audits, and ensure adherence to GLP (21 CFR Part 11 and Part 58).
- Create and maintain documentation including SOPs, configuration records, and validation protocols.
- Support end-users through training and troubleshooting, ensuring high-quality and timely resolution.
- Install, configure, deploy, and support business-critical applications according to company policy and industry best practices.
- Monitor application health, uptime, performance, and security, taking corrective action as needed.
- Collaborate with development, systems, and laboratory teams to improve application performance and usability.
- Respond to help desk tickets related to software applications and ensure issues are resolved promptly.
- Prepare reports and support documentation to meet business and regulatory needs.
- Support the qualification and validation of new systems and enhancements.
- Manage small to mid-size projects focused on software applications and system improvements.
- Primary POC for LIMS provider
- Other duties as assigned
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Role Requirements |
- Bachelor’s degree in Computer Science, Life Sciences, Information Systems, or a related field.
- This position does not include direct people management responsibilities. While prior management experience is not required, it will be regarded as a valuable asset.
- Minimum of 3 years of IT experience.
- Minimum of 3 years of hands-on experience administering LIMS, ELN, EHR, or comparable applications (e.g., LabWare, STARLIMS, LabVantage, Sapio, Thermo Fisher SampleManager).
- Solid understanding of software validation practices, data integrity principles, and regulatory requirements in pharmaceutical, biotech, or clinical lab environments.
- Foundational knowledge of laboratory operations, scientific workflows, and data capture methodologies.
- Familiarity with database systems (e.g., SQL); experience with scripting or programming is a plus.
- Knowledge of GLPs, 21 CFR Part 11 and Part 58, GDPR, and other relevant federal IT compliance standards.
- Proven ability to manage multiple priorities and meet deadlines in a fast-paced, dynamic environment.
- Strong analytical, communication, and organizational skills.
- Demonstrated ability to multitask effectively and adapt quickly to changing demands.
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Behavioral Expectations |
- Collaborative and team-oriented with excellent interpersonal skills.
- Maintains a service-first mindset and consistently provides high-quality user support.
- Stay calm and focused under pressure and during incidents.
- Demonstrates resilience, adaptability, and effective problem-solving in a dynamic work environment.
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Special Requirements |
- Project management experience or certification (e.g., PMP, Agile) is preferred.
- Willingness and ability to work in both office and laboratory settings (approximately 90% office, 10% lab).
- Potential exposure to chemicals, animal tissue, zoonotic organisms, and animal pathogens.
- Must be able to wear appropriate personal protective equipment (PPE), including N95 masks and respirators.
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