JOB SUMMARY
The IT Laboratory Data Systems Engineer is responsible for supporting and maintaining the company’s GxP laboratory applications and data systems, including ETQ Reliance (SaaS), Waters Empower, and laboratory instrument data backups. This role ensures system reliability, data integrity, documentation accuracy, and compliance with regulatory expectations while partnering closely with QA, IT, and Laboratory Operations.
PRIMARY DUTIES & RESPONSIBILITIES
- Administer and support ETQ Reliance SaaS, including users, workflows, permissions, and change control.
- Support Empower system configurations, product specs, calculations, and day-to-day administration.
- Perform and maintain laboratory instrument data backups, archiving, and data integrity controls.
- Perform audits of GMP systems, collaborate and presents findings to management.
- Troubleshoot application issues via the IT ticketing system; escalate to vendors when needed.
- Support Computer System Validation (CSV), including test scripts, IQ/OQ/PQ execution, and documentation.
- Maintain system SOPs, configuration documentation, release notes, and audit-ready records.
- Participate in application upgrades, patching and maintenance initiatives.
- Provide exceptional customer service to internal employees.
- Evaluates product enhancements and capabilities, in addition to implementing upgrades as required.
- Buildout existing systems according to end-user needs.
- Acts as liaison between internal laboratory users and vendor to address various system issues and user requirements.
- Create and support related documents, processes, and SOPs.
- Ensure compliance with GxP, 21 CFR Part 11, and data governance requirements.
REQUIREMENTS AND QUALIFICATIONS
Bachelor's Degree in IT, Computer Science, Life Sciences, or related field (or equivalent experience). Experience supporting GxP applications such as ETQ Reliance, or Waters Empower. Understanding of data integrity principles (ALCOA+), laboratory processes, and instrument data workflows.
MINIMUM SKILLS REQUIREMENTS
- Strong documentation, communication, and problem-solving skills.
- Perform all assigned duties on time and can adapt to changing priorities.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
