CSV Consultant (Full time Contract until Dec 2024)

Proclinical are recruiting for a CSV Consultant to join a pharmaceutical organisation. This role is on a contract basis and is located in Bern.

Responsibilities:

• You will plan, arrange, and implement all phases for computer system validation of both production and QC lab systems, which might involve validation plans, FMEA, RTM, DQ, IQ, OQ, PQ testing scripts, etc.
• Ensure that validation master plans are updated and formed for all ongoing projects.
• Responsible for assessing and creating the CSV package(s) on allocated projects as well as the work being created.
• Arrange and implement FAT/SAT, commissioning actions solely focusing on CSV for new systems.
• The ideal candidate will prepare, evaluate, and approve technical and GMP linked documentation such as URS, impact/risk assessment, master plans, qualification/validation documentation, etc.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a technical or natural science field.
• Demonstrable experience in a pharma or biotech organisation.
• Familiarity with outlining method and validating computerised manufacturing equipment.
• Demonstrable experience with CSV with expertise on linked needs rendering to FDA 21CFR part 11/ EUGMP Annex 11 guidelines and ISPE GAMP 5 regulations.
• Knowledge of qualification needs rendering to cGMP guidelines.
• Acquaintance with validating software and hardware infrastructure, such as servers, network and software services.
• Fluency in the English language with knowledge in German would be beneficial.

If you are having difficulty in applying or if you have any questions, please contact Sheridon Lloyd on +41 61 563 1243.

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.

#IT&DigitalTransformation