System Analyst /LIMS Analyst is required for a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market..
The Systems Analyst will:
o Perform second level application support, routine administration, and Master Data maintenance
o Perform investigations and root cause analysis
o Perform Business Analysis and technical lead duties for implementation projects
o Host/manage regular Super User meetings to gather new enhancement requests (User Requirements), identify training opportunities, and communicate status updates to the key users
o Ensure users understand and accept the solutions delivered to them by facilitating UAT, performing demonstrations, Conference Room Pilots, and training
o Assist with validation (risk assessments, technical guidance, discrepancies, Uses Cases etc.)
The Systems Analyst will need:
o 3rd level degree in a technical discipline (physical, engineering, chemical, biological or computer sciences)
o Training in project management and ITIL a plus
o 3- 5+ years experience in a cGMP regulated environment as a LIMS System Admin and Application Support, preferably in LabWare LIMS and Lonza MODA
o Experience supporting computer or lab systems in a GxP regulated environment (Change Control, Deviations, CAPA, Validation, 21CFR Part 11/EU Annex 11, etc.)
o Technical Documentation (SOPs, SDLC, Process Mapping) using standard office software.
o Business Process definition and engineering experience, or certification (Six sigma, LEAN, etc)
Call Amparo in LSC on 0214777 329 to discuss this Systems Analyst role in more detail or apply directly via this advert.