C&Q 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 for a C&Q Engineer to join a pharmaceutical organisation. This role is on a contract basis and is located in Bern.

Responsibilities:

Author/evaluate qualification plans, which may involve DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process / QC analytical equipment.
You will plan and track implementation of commissioning & qualification actions/documentation versus project(s) timeline.
Guarantee that qualification master plans are updated and formed for all ongoing projects.
You will prepare, evaluate and approve both technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, Master plans, qualification documentation, etc.
Arrange and implement FAT/SAT, commissioning actions for new GMP systems working alongside both internal and external partners.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in an engineering, technical or natural science field.
Demonstrable experience working within a pharma organisation in a C&Q/CQV corresponding role.
Knowledge of qualification needs rendering to cGMP guidelines.
Familiarity working with cross-divisional shareholders.
Knowledge of quality assurance principles as well as of present GMP standards and regulations connected to equipment, utilities and facilities qualifications, such as ISO, ICH, FDA, ISPE, etc.
Acquaintance working within a team and on various projects simultaneously.
Communication skills both verbally and in writing.
Able to think analytically with the ability to resolve issues.
Fluency in the English language with knowledge in German would be beneficial.
Able to manage own time efficiently.

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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