C&Q Engineer

vor 3 Wochen

Bern, Bern, Schweiz Randstad Vollzeit
Job Description

We are seeking a highly skilled C&Q Engineer to join our team at Randstad. The successful candidate will be responsible for Commissioning & Qualification activities for the Technical Services department.



Key Responsibilities:

  • 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.
  • Develop and maintain Qualification Master plans 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.
  • Execute 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.
  • Coordinate and oversee external suppliers.



Requirements:

  • Bachelor/Master's degree in Engineering, technical or natural sciences
  • A minimum of 5 years of working experience within pharma company in C&Q/CQV equivalent position
  • Knowledge of Qualification requirements according to cGMP regulations
  • Experience working with cross-department stakeholders
  • Knowledge 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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