C&Q Engineer

For our client, an international company based in Bern, we are looking for a C&Q Engineer.


General Information:
 

• Start date: ASAP, latest in January 2025

• Contract duration: 1 year with possibility of extension

• Workplace: Bern

• Workload: 100%

• Home office: possible up to 2 days per week

Tasks and Responsibilities:
 

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 and Skills:

• Bachelor/Master’s degree in technical or natural sciences

• Working experience within pharma/Medical Devices companies

• Practical experience in a C&Q role is a must

• 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