Beschreibung
CSV (Computer System Validation) Engineers required for one of Europe's largest Greenfield biotech projects. Our client is a world leader in biotechnology and is investing hugely in a state of the art facility in Switzerland.
3 Engineers are required to act as System Experts on the facilities Computer Systems ensuring interface across utilities, equipment, DCS Automation systems and IT.
Role
You will be leading a small team to write performance and report on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (eg automation).
You will drive validation activities from initiation to successful completion being the primary decision maker for assigned validation responsibilities, including deviation investigations, risk/impact assessment:
- Preparation and execution of validation protocols involving facilitates equipment, utilities, and associated automation.
- Preparation, review, and approval (as required) of SOPs, validation deviations, change control, validation summary reports, and associated documentation.
- Management and coordination of validation activities with internal departments, external contractors, and suppliers.
- Prepare and deliver cross-functional training in validation methodologies, protocols, and related procedures to facilitate validation activities.
- Primary point of contact for validation related issues arising during validation activities (including protocol execution).
- Investigation of deviations/non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements.
- Provides support to commissioning activities, including the review of commissioning plans, procedures, turnover packages etc. (as required).
- Represent validation as a subject matter expert (SME) in all project phases
- Support implementation of the following automation systems setup onsite; Delta V, Syncade (Emerson MES) and Historian 7.0 (GE).
- Provide full and efficient QA review of automated systems on site.
- Ensure accurate reporting of all deviations from QA perspective across data flow through above automation systems.
- Review and provide final sign-off on all automation documentation from QA perspective (GAMP compliance).
- Review all OOS (out of specification) data from the Syncade Workflow.
- Implement Review By Exception' mindset to the site
- Review of any deviations/changes of identified parameters in a dashboard & report the following;
- The reduction of manual entries/automation of manual entries
- The automation of decision points
- Incorporating equipment states/automation of state changes
- Automated sample tracking/status updates
- Allowing qualified systems to perform review, where possible/risk permitting (eg CIP records)
- The right level of review (by the System, Manufacturing, QA) of the right aspects by record type (Criticality/risk)
8-10 years of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment.
- Knowledge of Syncade
- Knowledge of PI Historian
- Large-scale project experience
- English fluent
- Bachelor of Science Degree (BSc) in an engineering or scientific discipline. MSc in a related discipline preferred
- CSV experience within Biotech facility
- Automation Systems experience (Delta-V)
- MES experience (Syncade WorkFlow)
- CGmp/CGAMP experience