CSV Junior Engineer

Job content

An industry leader in pharmaceuticals is looking for a Junior CSV Engineer to assist in the Computer System Validation (CSV) activities for Technical Services department and start growing within an exciting role.

Main Responsibilities

Assess and handle quality issues and corrections or CAPAS associated under the scope of CSV.

Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.

Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)

Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners

Main requirements

Bachelor/master’s degree in technical or natural sciences

A minimum of 1 year working experience within pharma or a biotech company

Initial experience on validating software & hardware infrastructure (e-g: Servers, network and software services).

Know-how of CSV requirements according to FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines

For more information, feel free to reach out to (see below)

Job Title: CSV Junior Engineer

Location: Bern, Switzerland

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.

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We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.