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.
- 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.