Provide hands-on end-user support, administration, installation, and issue resolution for GxP controlled laboratory equipment, servers, desktops, and software packages.
Perform laboratory upgrades (software, desktop components, etc.), create/review/approve system documentation, and author/execute test scripts as needed.
Role Functions (Functions include, but are not limited to):
IT Lab Analyst
Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
Perform laboratory equipment, hardware, and software upgrades following corporate computer system validation policies and GMP best practices.
Represent IT on digital strategies within QC, MS&T, and Manufacturing analytical equipment.
Collaborate with Global IT teams on LIMS, Empower, and Mode upgrades/enhancements and issue resolutions.
Execute routine system administration and maintenance activities.
Create and/or execute software validation scripts to support laboratory operations.
Create and maintain system documentation including system design specifications, user requirements, functional requirements, or routine controlled application change forms.
Proactively communicate with laboratory stakeholders and update helpdesk tracking software as necessary.
Ensure proper user management processes are followed for all computerized systems.
Administer lab system access requests.
Participate in or lead audits of computerized system software/solutions providers.
Ensure systems comply with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, EU Annex 11, Data Integrity standards, and guidelines.
Collaborate closely with CSV Lead, System Integrator, and site team.
Prepare and complete all System Design Configuration Specification documentation.
Coordinate with CQV and site engineering teams for successful startup of facilities.
Work with operational readiness teams and operations to ensure smooth turnover.
Support internal and agency inspections.
Provide SME support for troubleshooting, problem-solving, and technical guidance to meet business needs.
Qualifications & Education:
Bachelor's degree in a technical discipline
Experience with QC Lab analytical instrumentation qualification and system implementation
Excellent written and oral communication skills
Ability to multitask and manage competing priorities effectively
Strong technical aptitude, experience with global regulatory standards, and interfacing with regulators
Experience working in a multinational organization
Experience delivering training on site quality system procedures