CSV Validation Engineer

On behalf of our major client we are looking for a contract position for CSV Validation Engineers (Location: Solothurn or Ticino)

Responsibilities:

Working as PQS (CSV Validation Engineer) for the validation of Legacy software and software validation of production equipment. Creation of all needed documents to get the system complaint with the regulations.

Tasks:

- Support and consulting during projects handling GxP critical computer systems
- Creation of the Validation documentation for GxP relevant systems.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations.

Extended duties:

- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).

Required skills:

- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- Responsibility in similar position or extended experience as executer required.
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11.
- Fluent English and German for Solothurn; Fluent in English and Italian for the position in Ticino

Are you interested in this position? We are looking forward to receive your application.

Many thanks.