CSV Engineer (6388)

The Life Science Career Network – CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CSV Engineer for a 10 months contract

CSV Engineer – 6388 ASH

Main 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 live

•      Supervision of deviations, changes (GEP and GMP), and CAPAs

•      Coordination of CSV executions with internal groups, as well as external service providers and suppliers

•      Responsible for the presentation of CSV documents during audits and inspections

•      Scheduling and reporting of CSV activities

•      Following the alignment of the CSV strategy with the QA CSV for all Biologics scope

•      Contribution in the review and amelioration of all CSV documents

Qualifications and Experience:

·     Relevant working/residency permit or Swiss/EU-Citizenship required

•      Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field

•      Significant experience in a regulated environment with regard to Computerized System Validation (CSV)

•      Good knowledge of Microsoft Office and Delta-V is required

•      Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise and SAP is an advantage

•      Fluent in English, German language skills are advantageous

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.