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Qualification and Validation Engineer: German, Medical Devices
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Engineer, Natural
Projektbeschreibung
Qualification and Validation Engineer: GERMAN, Medical Devices
A world renowned pharmaceutical and medical device manufacturer is seeking a German speaking qualification and validation engineer for (new) biopharmaceutical processes in the early and late Stage development department in order to ensure that:
-Validation/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
*Plan, Coordinate and execute all phases for validation/qualification of equipment and computer system validation including impact/risk assessment, DQ, IQ, OQ
*Prepare, review and approve technical and GMP related documentation (URS, qualification documentation)
*Supporting the commissioning activities for new equipment and supporting the user in issuing URS
*Coordinate and execute FAT/SAT, commissioning activities in collaboration with internal and external partners
*Coordination and oversight of external qualification partners
*Operational handling of Change Controls, CAPAs and Non-Conformances related to process equipment and cleaning
*Bachelor/Master Degree in technical or natural sciences
*A minimum of 3 years of working experience within pharma or a biotech company
*Experience in the pharma/biotech Fill Finish environment is a plus
*Basic Know-how of biotechnology processes
*Profound Know-how of Validation/Qualification requirements according to cGMP
*Know-how of quality assurance principles
*Analytical thinking and problem solving ability
*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
A world renowned pharmaceutical and medical device manufacturer is seeking a German speaking qualification and validation engineer for (new) biopharmaceutical processes in the early and late Stage development department in order to ensure that:
-Validation/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
*Plan, Coordinate and execute all phases for validation/qualification of equipment and computer system validation including impact/risk assessment, DQ, IQ, OQ
*Prepare, review and approve technical and GMP related documentation (URS, qualification documentation)
*Supporting the commissioning activities for new equipment and supporting the user in issuing URS
*Coordinate and execute FAT/SAT, commissioning activities in collaboration with internal and external partners
*Coordination and oversight of external qualification partners
*Operational handling of Change Controls, CAPAs and Non-Conformances related to process equipment and cleaning
*Bachelor/Master Degree in technical or natural sciences
*A minimum of 3 years of working experience within pharma or a biotech company
*Experience in the pharma/biotech Fill Finish environment is a plus
*Basic Know-how of biotechnology processes
*Profound Know-how of Validation/Qualification requirements according to cGMP
*Know-how of quality assurance principles
*Analytical thinking and problem solving ability
*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
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik