C&Q Engineer

Posted 13 October 2021
Job type Limited
DisciplineQuality Assurance/Safety, Engineering

Job description

For our client Johnson and Johnson in Bern, we are currently looking for a new team member as

C&Q Engineer

* 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:
- Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Qualification/Validation Master plans are up to date and established for all ongoing projects
* Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
* Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
* Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
* Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
* Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
* Coordination and oversight of external suppliers

* Bachelor/Master's degree in technical or natural sciences
* A minimum of 5 years of working experience within pharma company in C&Q/CQV equivalent position
* Know-how of Qualification requirements according to cGMP regulations
* Experience working with cross-department stakeholders
* Know-how of quality assurance principles
* Experience working in project teams and multiple projects in parallel
* Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
* Excellent communication skills
* Analytical thinking and problem-solving ability
* Business fluency in English
* German language is a plus
* Self time management

Workplace: Bern
Workload: 100%
Working Time: flexible working hours
Start Date: 01.11.2021
Duration: 6 months

Your Application
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).