Commissioning & Qualification Engineer 100%

Posted 05 August 2022
Salary Verhandelbar
LocationZuchwil
Job type Limited
DisciplineEngineering
ReferenceBBBH552103_1659713211

Job description

For a leading international pharmaceutical company, we are looking for a

Commissioning & Qualification Engineer

In this position you will perform Commissioning & Qualification activities for the Technical Services department of our client.


Tasks & Responsibilities

  • 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

Requirements

  • Bachelor/Master's degree in technical or natural sciences
  • A minimum of 2 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
  • Business fluency in English
  • Excellent communication skills
  • Analytical thinking and problem-solving ability


Nice to have

  • Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
  • German language is a plus


General Information

Workplace: Bern
Workload: 100%
Start date: asap
Duration: until the end of 2022


Your application

Please apply online. For further information about the position, please contact Nicole Blum [].