C&Q Engineer
Job description - JJJP00021312
Job Title: C&Q Engineer Job Subfunction: Quality Duration: 06/01/2025 to 31/12/2025 Start: 06/01/2025
This role is for 1 year + possible extension. We need someone pharma background and Q&C experience. We need someone already living in Bern (or close) and can start to work in January latest. This project requires to be on site 3 days per week. The JD description is precise, please don't submit profiles without C&Q experience.
The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:
- (re
- ) qualification of production/QC equipment including thermal mapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Commissioning & Qualification Master plans are up to date and established for all ongoing projects.
- Write/review Commissioning & Qualification plans and reports.
- Execution of RQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities
- Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelines
- Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners
Coordination and oversight of external suppliers Qualifications:
Bachelor/Master’s degree in technical or natural sciences
- Working experience within pharma/Medical Devices companies
- Know
- how of Qualification requirements according to cGMP regulations
- Know
- how of thermal mapping studies
- Know
- how of quality assurance principles
- Excellent communication skills
- Analytical thinking and problem
- solving ability
- Business fluency in English
- German language is a plus
- Self time management Education Required:
University/Bachelors Degree or Equivalent
FTE/volume in %
100
Job Function
Quality
Job Subfunction
Validation
Work Experience
Generally Requires 2 - 4 Years Work Experience