Desktop Support Engineer- Pharmaceutical Labs
This is an excellent opportunity to join this state-of-the art new build Dublin based project.
You will be required to provide hands-on end user support, administration, installation and issue resolution for GxP controlled laboratory equipment, servers, desktops and software packages, as well as work on laboratory upgrades (software, desktop components, etc) create system documentation and author/execute test scripts as needed.
As IT Lab Analyst you will be involved in the following duties:
- Troubleshoot and resolve technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces
- Perform laboratory equipment, hardware and software upgrades following corporate computer system validation policy and GMP best practices
- Coordinate with users and vendors to facilitate timely resolution of software / hardware issues
- Create and/or execute software validation scripts to support laboratory
- Create and maintain system documentation including system design specifications, user requirements, functional requirements or routine controlled application change forms.
- Participates in or leads computerised system software/solution provider audits.
- Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines.
- Work closely with AIQ Lead, System Integrator and site team
- Prepare & complete all System Design Configuration Specification documentation.
- Ensure project documentation and handover completeness;
Skills & Experience Requirements
- Bachelor’s Degree in a technical discipline - ideally
- At least 4 years’ experience in the biotechnology and/or pharmaceutical industry
- Prior QC Lab experience with analytical instrumentation qualification and system implementation
- Knowledge of regulations and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.
- Excellent communication skills (written and oral)
- Ability to multi-task and handle tasks with competing priorities effectively
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