CSV Engineer

Highly Competitive
  1. Permanent
  2. Validation
  3. Switzerland
Bern, Switzerland
Posting date: 20 Oct 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a CSV Engineer to join a pharmaceutical organisation. This role is on a contract basis and is located in Bern with 40% remote working available.


  • Responsible for the work to be created by yourself and any other colleagues that are under the allocated packages guided by this position.
  • Examine and guide the CSV package(s) on an allocated project.
  • Conduct CSV periodic evaluation and systems validation planning for base business which involves interaction with IT, maintenance automation and quality operations groups.
  • Arrange and implement FAT/SAT, commissioning actions oriented around CSV for new systems in cooperation with internal and external partners.
  • Manage change controls, CAPAs and non-conformances connected to CSV.
  • You will prepare, evaluate and approve technical and GMP linked documentation such as URS, impact/risk assessment, Master plans, qualification/validation documentation, etc.
  • Any other assigned duties.

Key Skills and Requirements:

  • Educated to a degree level in a technical or natural science field.
  • Capable of working within a fast-changing setting.
  • Demonstrable experience working in a pharma or biotech organisation.
  • Familiarity with validating computerised manufacturing equipment in a CSV context.
  • Acquaintance with validating software and hardware infrastructure such as servers, network and software services.
  • Demonstrable experience working with CSV.
  • Knowledge of CSV needs rendering to FDA 21CFR part 11/ EUGMP Annex 11 guidelines and ISPE GAMP 5 regulations.
  • Communication skills both verbally and in writing.
  • Able to think analytically and resolve issues.
  • Capable of working under minimal supervision while prioritising workload within a fast-paced setting.
  • Works well while under pressure.
  • Able to work as part of a multidisciplinary, global team.
  • Fluency in the English language with knowledge in German.
  • Past involvement in validating multifaceted computerised analytical equipment such as QC laboratory equipment.
  • Knowledge of validation needs rendering to cGMP guidelines.
  • Expertise on quality assurance principles.

If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at +41 61 508 73 40.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.