Beschreibung
Project Information:Our client, a global (bio) pharmaceutical organisation, is currently investing across different areas at their facility in Austria. The primary investment as part of this is a new Lab facility build.
The lab will house the QC and MS&T capabilities.
Duties/Deliverables/Measurable's for the role:
- Taking responsibility for the Validation plan and implementation during the new Lab facility build on site.
- The Validation Engineer will be required to be responsible for the execution and review of all life cycle validation documentation for the qualification of laboratory process equipment and associated utilities within a highly-regulated Biopharmaceutical manufacturing environment.
- Review/produce supporting validation documentation, as required, as part of a validation exercise.
- Co-ordinate with other groups with responsibilities for equipment validation activities directly related to validation, eg Project Engineering.
- Provide up to date information to Line Management on activities and time lines relating to validation work, utilising appropriate techniques.
- IQ, OQ, PQ, PV activities.
- German literate is a must.
- Knowledge and experience of lab equipment.
- Solid experience of project life cycle validation activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
- Ability to train and operate within a sterile manufacturing facility.