CSV Engineer job in Bern, Switzerland

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Job type: Contract

Discipline: Validation

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting a CSV Engineer for a pharmaceutical organisation. This role is on a contract basis and is located in Bern. The client is focused on creating a healthier community.

Responsibilities:

Manage operations such as change controls, CAPAs and non-conformances linked to CSV.
Assist the technical services division KPI.
Guarantee the CSV procedure connected processes and life cycle management are up to date rendering to global GMP standards and internal processes.
Plan, assess and consent to technical and GMP correlated reports such as URS, impact/risk assessment, Master plans, qualification/validation documentation.
Handle preparing validation actions for base organisation which involves networking with IT, maintenance automation and quality operations groups.
Organise and implement FAT/SAT, commissioning actions focused on CSV for new systems in cooperation with affiliates on an internal and external level.
Other duties may be assigned to this role.

Skills & Requirements:

Educated to a degree level in a technical science, natural science or similar discipline.
At least 3 years of experience in a pharma or biotech industry.
Knowledge of CSV needs rendering to FDA 21CFR Part11/EU GMP Annex11 guidelines and ISPE GAMP5 regulations.
Qualification necessities conferring to cGMP principles know-how.
Capable of directing and implementing CSV validations on manufacturing equipment and higher-level systems such as ISA-95 2 and 3.
Familiarity with CSV validation for infrastructure systems such as networkwide infrastructure and virtualisation.
Past involvement with IT or automation systems.
Acquaintance with CSV validation of analytical equipment.
Knowledge of quality assurance protocols.
CAPAs experience.

If you are having difficulty in applying or if you have any questions, please contact Sasha Botha at +41 61 568 79 88.

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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