Great opportunity for an experienced CSV Engineer to work onsite with our biotech client in Limerick.
As CSV Engineer you will uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
As CSV Engineer your primary responsiblities will be:
o Generation, execution, review & approval of IOQ protocols and associated validation documents and CSV assessments e.g. Part11 Assessments, etc. related to IT Infrastructure systems and related IT Applications and system components
o Prepares/reviews validation documentation related to projects/change controls.
o Manages change controls and other compliance related tasks e.g. non-conformances.
o Participates in the review of current and future CSV procedures and polices
o Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
o Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
As CSV Engineer you wil have:
o Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
o Experience in a GMP environment essential.
o Biologics experience highly desirable
For full details on this role please contact Kathy Gillen at 021477739 or email@example.com or apply directly through this advert.