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Validation Engineer

Michael Bailey Associates - UK Contracts

Posted on Nov 13, 2021 by Michael Bailey Associates - UK Contracts

Bern, Switzerland
Research
1 Jan 2022
Annual Salary
Contract/Project

A Pharmaceutical company is searching for:

Validation Engineer (CSV)

Main Responsibilities

- Coordination of computerized system qualification and validation activities within the Quality Control department

- Define the validation strategy

- Perform and/or support the writing of specification documents (URS)

- Review test protocols, plans and reports

- Support test execution

- Support and train team members in CSV methodology

- Supporting the timely and effective completion of investigations, change controls and CAPA's

Requirements:

- Degree in a LifeSciences/Biotechnology, Chemistry discipline or comparable work experience

- Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)

- Good understanding of analytical technologies,

- Strong analytical thinking and problem-solving ability

- Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly

- Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.

- Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.

- Good verbal and written skills in English, German is a plus

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 1397189212

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