C&Q Engineer

vor 4 Wochen


Bern, Schweiz Randstad (Schweiz) AG Vollzeit

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

General Information:
  • Start date: ASAP
  • End date: 31.12.2024
  • Extension: possible, to be discussed
  • Workplace: Bern
  • Workload: 100%
  • Home office: possible up to 2 days per week
Tasks and Responsibilities:

The position will report to the C&Q Manager and is in charge of Commissioning & Qualification (C&Q) activities for the Technical Services department in order to ensure that:

  • Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
  • Qualification Master plans are up to date and established for all ongoing projects.
  • Write/review Qualification plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process/QC analytical 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 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.
Qualifications and Skills:
  • Bachelor/Master’s degree in Engineering, technical or natural sciences
  • A minimum of 5 years of working experience within a 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
  • Knowledge of current GMP standards and guidelines related to equipment, utilities and facilities qualification (ISO, ICH, FDA, ISPE)
  • Excellent communication skills
  • Analytical thinking and problem-solving ability
  • Business fluency in English, German language is a plus
  • Self time management skills
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