GxP Laboratory Systems Administrator

Responsibilities
Business:
- Support and system administration for identified applications
- Investigate and resolve technical and business process issues
- Communicate issues/resolutions with users and department managers
- Escalate issues to application vendors as necessary
- Troubleshoot and collaborate with end users and departmental managers
- Maintain functional subject matter knowledge for assigned applications
- Perform other duties as assigned

Regulatory:
- Perform periodic application review and manage user access
- Represent application documentation in client and regulatory audits
- Contribute to audit finding responses
- Contribute to CSV/CSA/computer system validation and software assurance projects, including application change control as required by GxP, policies, and SDLC
- Draft CSV/CSA documentation (validation plans, design specs, traceability matrices, user requirements, test scripts, deviations, summary reports)

Information Systems/Informatics:
- Coordinate communication between business and IS/Informatics
- Triage escalation of technical issues
- Update global systems inventory for applications
- Coordinate releases into Development, Testing, and Production environments
- Develop business scenarios to test applications
- Verify installation and operation
- Document analysis/testing for infrastructure changes (e.g., OS patches, major network changes)

Requirements:
- Bachelor’s in CS or life sciences (or related field) or equivalent experience
- 4+ years administering/operating/maintaining LIMS, chromatography data systems, spectrophotometry systems, and related lab systems in a GxP environment
- Advanced knowledge of computer programs (e.g., MS Word/Excel, data acquisition systems)
- Ability to multi-task across projects and initiatives
- Ability to deliver high-quality results under strict deadlines
- Ability to work independently and with others

Preferred:
- Experience validating/supporting Agilent systems (Openlab, Chemstation, Cary UV)
- Knowledge of GxP/CSV-CSA/21 CFR Part 11/EU Annex 11/SDLC
- Experience with regulated asset management and environment monitor applications
- Computer System Validation and GxP (21 CFR Part 11, Annex 11)
- Pharmaceutical or CRO experience
- Project Management certification

Benefits (if part of description):
- Competitive salaries and an excellent benefit package

Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.