Orca Bio · 1 month ago
System Administrator, Enterprise Systems
Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. The System Administrator, Enterprise Systems will be responsible for the administration and management of the Laboratory Information Management System (LIMS) and other enterprise systems, ensuring system reliability, data integrity, and compliance with regulatory requirements.
Health CareMedicalPharmaceutical
Responsibilities
Support the implementation and validation of a new LIMS system including requirements gathering, configuration and testing
Assist with configuration and administration of enterprise systems
Perform day-to-day administration for enterprise systems including user account provisioning, role/permission management and system configuration changes
Partner with developers to plan system enhancements, gather requirements, and support user testing and validation
Conduct periodic system and audit trail reviews to ensure compliance with 21 CFR Part 11, GxP regulations (including but not limited to GMP), and internal policies
Monitor system performance and troubleshoot issues
Support internal and external audits as needed for enterprise systems
Provide frontline support and assistance to LIMS end users to ensure end users can perform their day-to-day duties
Implement new modules for various enterprise systems to help shape the design, configurations, and workflows for future states
Support testing for enterprise systems including preparing test plans, evaluating test results for application implementations, modifications or upgrades
Qualification
Required
5+ years of experience with a Quality Control background in a regulated industry, such as antibodies, proteins, and reagent testing or pharmaceutical manufacturing
3+ years of experience administering a LIMS system in a regulated (biotech, pharma, medical device) environment
Hands-on experience with electronic quality management systems (e.g. MasterControl, Veeva, TrackWise, etc.)
Demonstrated experience with supporting or integration with Tech Ops systems including MES, eBR, QMS, LMS, and DMS
Experience in FDA requirements for 21 CFR Part 11 (data integrity, audit trail review, and all other applicable compliance requirements)
Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams including IT and lab personnel
Benefits
Pre-IPO equity
Competitive medical, dental, and vision benefits
Flexible PTO
401(k) plan
Life and accidental death and disability coverage
Parental leave benefits
Free daily lunches and snacks at our on-site locations
Company
Orca Bio
Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.
H1B Sponsorship
Orca Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$542MKey Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M
Recent News
2026-01-12
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-12
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