Qualification Engineer-00000V1I
Beschreibung
"Caring for the world... one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
Crucell is a biopharmaceutical company and part of the Johnson and Johnson Family of Companies. Crucell Switzerland AG announced that it will produce an experimental Ebola vaccine at its site in Bern. The company aims to manufacture one million doses of the vaccine regimen in 2015, a quarter of which are expected to be released for broad application in clinical trials by May 2015.
Qualification Engineer
Your tasks:
- Partnering with production teams, analytics and quality organisations in defining, developing, executing and reporting cleaning verification/validation activities and/or sterilisation/decontamination processes
- Bridging with cross-functional teams handling preventive maintenance, equipment calibration and repair and ensuring equipment readiness for production
- Coordinating with production, finance, engineering and EHS the commissioning activities for new equipment and supporting the user in issuing URS
- Supporting engineering, quality and production in a campus-wide qualification team focused on planning, coordinating and executing all phases of equipment qualification (Impact Assessment, DQ,IQ,OQ, PQ)
- Participation in FAT and SAT processes and execution/oversight of acceptance tests related to cleaning/sterilisation processes
- Coordination and oversight of external qualification partners
- Operational handling of Change Controls, CAPAs and Non-Conformances related to process equipment and cleaning
- Authoring of work instructions, SOPs and technical presentations
- Acting as subject matter expert during inspections and audits
Qualifikationen
- Engineering or science background
- A minimum of 3 years of working experience within pharma or a biotech company
- Business fluency in German and English is a must
- Furthermore we are looking for a team player, self-starter, multitasker and a good time manager
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).
Primärer Standort: Europa/mittlerer Osten/Afrika-Schweiz-Bern-Bern
Organisation: Crucell Switzerland AG (8851)
Funktion: Validation
Beschreibung
"Caring for the world... one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
Crucell is a biopharmaceutical company and part of the Johnson and Johnson Family of Companies. Crucell Switzerland AG announced that it will produce an experimental Ebola vaccine at its site in Bern. The company aims to manufacture one million doses of the vaccine regimen in 2015, a quarter of which are expected to be released for broad application in clinical trials by May 2015.
Qualification Engineer
Your tasks:
- Partnering with production teams, analytics and quality organisations in defining, developing, executing and reporting cleaning verification/validation activities and/or sterilisation/decontamination processes
- Bridging with cross-functional teams handling preventive maintenance, equipment calibration and repair and ensuring equipment readiness for production
- Coordinating with production, finance, engineering and EHS the commissioning activities for new equipment and supporting the user in issuing URS
- Supporting engineering, quality and production in a campus-wide qualification team focused on planning, coordinating and executing all phases of equipment qualification (Impact Assessment, DQ,IQ,OQ, PQ)
- Participation in FAT and SAT processes and execution/oversight of acceptance tests related to cleaning/sterilisation processes
- Coordination and oversight of external qualification partners
- Operational handling of Change Controls, CAPAs and Non-Conformances related to process equipment and cleaning
- Authoring of work instructions, SOPs and technical presentations
- Acting as subject matter expert during inspections and audits
Qualifikationen
- Engineering or science background
- A minimum of 3 years of working experience within pharma or a biotech company
- Business fluency in German and English is a must
- Furthermore we are looking for a team player, self-starter, multitasker and a good time manager
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).
Primärer Standort: Europa/mittlerer Osten/Afrika-Schweiz-Bern-Bern
Organisation: Crucell Switzerland AG (8851)
Funktion: Validation