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 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 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
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 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 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
