For our client, an international company in Lucerne, we are looking for a Commissioning & Qualification Engineer (P2 level)
- Start date: ASAP
- End: 30.11.2024
- Extension: possible
- Workplace: Lucerne
- Workload: 100%
Our Biologics Analytical Department located in Switzerland is part of ... global Biologics Analytical R&D. We are developing innovative biopharmaceuticals with state of the art technology. We currently offer an attractive position for a scientist or engineer with biochemistry or biotechnology background. The candidate will work in a global team with our counterparts in the U.S., Ireland and the Netherlands. The position offers development potential and responsibilities can be adjusted to the candidate’s qualifications and ambitions.
Tasks & Responsibilities:
- The Comissioning & Qualification Engineer role oversees and supports the qualification of analytical instrumentation and Computer Systems Validation (CSV) projects within the GMP environment. Responsibility of this function is to maintain the analytical laboratories and implement new systems in a state of permanent inspection readiness.
- System validation: Perform SDLC (Software development life cycle) validation
- Familiarity with analytical instrumentation used within the pharmaceutical industry
- Demonstrated ability for taking initiative and innovative problem solving
- Coordinate and conduct equipment qualification and software validation
- Analytical Metrology: Perform, coordinate and overview equipment calibration and maintenance
- Daily communication and coordination with lab heads and managers on open tasks
- Productivity and efficiency working in GMP laboratories
- Thorough understanding of GMP policies and procedures and proven experience working with Quality
- Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment
Day in the job:
- Qualify new equipment and validate software as needed
- Coordinate and conduct maintenance and calibration of analytical equipment
- Write SOPs, Changes and period review documents for equipment
- Typical start date between 7:00 and 9:00 am
Must Haves:
- Technician education (Apprenticeship) in Biotech, IT or Pharmaceutical industry
- Bachelor’s degree, in analytical chemistry/biotechnology/biochemistry or related field (IT) with experience in metrology, qualification, and computer system validation
- Experience in analytical equipment commissioning and qualification within a GMP environment
- Experience with computerized testing equipment and corresponding software.
- Strong oral and written communication skills in English (B1) and German (B2).
- Strong documentation skills on technical documents, attention to detail
For our client, an international company in Lucerne, we are looking for a Commissioning & Qualification Engineer (P2 level)
- Start date: ASAP
- End: 30.11.2024
- Extension: possible
- Workplace: Lucerne
- Workload: 100%
Our Biologics Analytical Department located in Switzerland is part of ... global Biologics Analytical R&D. We are developing innovative biopharmaceuticals with state of the art technology. We currently offer an attractive position for a scientist or engineer with biochemistry or biotechnology background. The candidate will work in a global team with our counterparts in the U.S., Ireland and the Netherlands. The position offers development potential and responsibilities can be adjusted to the candidate’s qualifications and ambitions.
Tasks & Responsibilities:
- The Comissioning & Qualification Engineer role oversees and supports the qualification of analytical instrumentation and Computer Systems Validation (CSV) projects within the GMP environment. Responsibility of this function is to maintain the analytical laboratories and implement new systems in a state of permanent inspection readiness.
- System validation: Perform SDLC (Software development life cycle) validation
- Familiarity with analytical instrumentation used within the pharmaceutical industry
- Demonstrated ability for taking initiative and innovative problem solving
- Coordinate and conduct equipment qualification and software validation
- Analytical Metrology: Perform, coordinate and overview equipment calibration and maintenance
- Daily communication and coordination with lab heads and managers on open tasks
- Productivity and efficiency working in GMP laboratories
- Thorough understanding of GMP policies and procedures and proven experience working with Quality
- Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment
Day in the job:
- Qualify new equipment and validate software as needed
- Coordinate and conduct maintenance and calibration of analytical equipment
- Write SOPs, Changes and period review documents for equipment
- Typical start date between 7:00 and 9:00 am
Must Haves:
- Technician education (Apprenticeship) in Biotech, IT or Pharmaceutical industry
- Bachelor’s degree, in analytical chemistry/biotechnology/biochemistry or related field (IT) with experience in metrology, qualification, and computer system validation
- Experience in analytical equipment commissioning and qualification within a GMP environment
- Experience with computerized testing equipment and corresponding software.
- Strong oral and written communication skills in English (B1) and German (B2).
- Strong documentation skills on technical documents, attention to detail
