Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Qualification & Validation Engineer
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Engineer, Natural
Projektbeschreibung
Role: CH- Qualification and Validation Engineer- Normal
Place of work: Bern
Beginning of employment: 02.08.2016
End of employment: 31.03.2017
Workload/weekly working hours: 100%/40 hours
Your tasks:
. In charge of qualification/Validation activities for (new) biopharmaceutical processes in the Late Stage Development department in order to ensure that: Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
. Plan, Coordinate and execute all phases for qualification of rooms, UAF and equipment including impact/risk assessment, DQ, IQ, OQ, PQ
. Execute CSV activities linked to the equipment
. Plan, Coordinate and execute all phases for validation activities including cleaning agent validation
. Prepare, review and approve technical and GMP related documentation (URS, qualification and Validation 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
. Acting as subject matter expert during inspections and audits
Non Technical Skills and Additional Details
* 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 Qualification/Validation requirements according to cGMP
* Know-how of quality assurance principles
* Analytical thinking and problem solving ability
* Business fluency in English is a must
* Furthermore we are looking for a team player, self-starter, multitasker and a good time manager
Place of work: Bern
Beginning of employment: 02.08.2016
End of employment: 31.03.2017
Workload/weekly working hours: 100%/40 hours
Your tasks:
. In charge of qualification/Validation activities for (new) biopharmaceutical processes in the Late Stage Development department in order to ensure that: Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
. Plan, Coordinate and execute all phases for qualification of rooms, UAF and equipment including impact/risk assessment, DQ, IQ, OQ, PQ
. Execute CSV activities linked to the equipment
. Plan, Coordinate and execute all phases for validation activities including cleaning agent validation
. Prepare, review and approve technical and GMP related documentation (URS, qualification and Validation 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
. Acting as subject matter expert during inspections and audits
Non Technical Skills and Additional Details
* 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 Qualification/Validation requirements according to cGMP
* Know-how of quality assurance principles
* Analytical thinking and problem solving ability
* Business fluency in English is a must
* Furthermore we are looking for a team player, self-starter, multitasker and a good time manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Ingenieurwesen/Technik