CSV Engineer

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.

Responsibilities:

• 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.

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