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Qualification Engineer (German & English)
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Engineering, Engineer, Natural, Client
Projektbeschreibung
Qualification Engineer
Randstad Professionals is actively looking for a German and English speaking Qualification Engineer to join their international biopharmaceutical client in Bern, Switzerland.
Your Responsibilities will include:
Being in charge of validation/qualification activities for (new) biopharmaceutical processes in the 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)
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/validation team and coordinate equipment tracking
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
Authoring of work instructions, SOPs and technical presentations
Minimum requirements:
University degree in natural or technical sciences or equivalent
A minimum of 3 years of working experience within pharma or a biotech company
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
If you are up for a new project and fulfil the mentioned requirements, don't hesitate to send in your application!
Good to know you
Charlotte
Randstad Professionals is actively looking for a German and English speaking Qualification Engineer to join their international biopharmaceutical client in Bern, Switzerland.
Your Responsibilities will include:
Being in charge of validation/qualification activities for (new) biopharmaceutical processes in the 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)
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/validation team and coordinate equipment tracking
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
Authoring of work instructions, SOPs and technical presentations
Minimum requirements:
University degree in natural or technical sciences or equivalent
A minimum of 3 years of working experience within pharma or a biotech company
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
If you are up for a new project and fulfil the mentioned requirements, don't hesitate to send in your application!
Good to know you
Charlotte
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik