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
• 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:
 

• 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.

• 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
• 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