CSV ConsultantBiologics - Contract - OnsiteProclinical is currently supporting a Global Biopharmaceutical manufacturing partner to recruit a CSV Consultant:
Biologics (m/f/d).
In this position you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES.You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as make a contribution to the ongoing optimization of processes, facilities and internal procedures.Responsibilities:
Preparation of commissioning and validation documents for new systems, as well as the supervision of conversion, expansion and new construction projects.
This is broken down into CSV activities on new construction projects for critical systems and SLC support for all systems after going liveSupervision of deviations, changes (GEP and GMP), and CAPAsCoordination of CSV executions with internal groups, as well as external service providers and suppliersResponsible for the presentation of CSV documents during audits and inspectionsScheduling and reporting of CSV activitiesFollowing the alignment of the CSV strategy with the QA CSV for all Biologics scopeContribution in the review and amelioration of all CSV documentsKey Skills & Requirements:
Required:
minimum 7 years in CSV in Biotech or Pharma (not Medical Devices CSV experience)Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical fieldSignificant experience in a regulated environment with regard to Computerized System Validation (CSV)Good knowledge of Microsoft Office and Delta-V is requiredKnowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise and SAP is an advantageFluent in English, German language skills are advantageous Proclinical VispWallis
