C&Q Engineer

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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