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.
- You will plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
- The ideal candidate will prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
- Ensure that Qualification/Validation Master plans are updated and formed for all ongoing projects.
- Author/evaluate qualification/validation plans, which may involve DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
- Implement DQ, IQ, OQ, PQ, which involves protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
- Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a technical or natural scientific field.
- Demonstrable experience in a pharma organisation within a C&Q/CQV corresponding role.
- Knowledge of qualification needs to cGMP guidelines.
- Familiarity working with cross-department shareholders.
- Knowledge of quality assurance principles.
- Acquaintance working within project teams and various projects in parallel.
- Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
- Communication skills both verbally and in writing.
- Able to think analytically with the ability to resolve issues.
- Fluency in English with knowledge in German would be advantageous.
- 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.