CSV Engineer job in Bern, Switzerland

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Job type: Permanent

Discipline: Validation

Location: Switzerland

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.

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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