Qualification & Validation Engineer

Vertragsart:
Vor Ort
Start:
keine Angabe
Dauer:
keine Angabe
Von:
Harvey Nash IT Recruitment Switzerland
Ort:
Bern
Eingestellt:
12.07.2016
Land:
flag_no Schweiz
Projekt-ID:
1165784

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Role: CH- Qualification and Validation Engineer- Normal

Place of work: Bern

Beginning of employment:

End of employment:

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