R

Cqv engineer

Randstad - High priority

Onbekend
ongeveer 1 jaar geleden
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R

Cqv engineer

Randstad - High priority – Stein (6170)

Contract: Uren: Salaris:

Job description

Jobdescription

CQ Engineer

For our Client abiopharmaceutical company in the Aargau we are currently seeking anumber of CQ engineers.The C & Q Execution Engineer isprimarily responsible for the execution of the CQV activitiescorresponding to their project area’s equipment andprocesses.

 

KeyResponsibilities:

  • SystemBoundary development +approval

  • DesignQualification preparation, execution and approval. Includes releasefor IQ.

  • Good ManufacturingPractice (GMP) Rapid Alertreviews

  • Commissioningpreparation, execution and approval. Includes vendor supervision ontheir testing, scope andquality.

  • InstallationQualification preparation, execution and approval. Includes releasefor OQ.

  • OperationalQualification preparation, execution and approval. Includes releaseto OPS.

  • Provide support inexecution of Design Qualification for other direct impactsystems.

  • Provide support inthe implementation of the installation commissioningprocess

 

Qualifications

  • Bachelor’sdegree in Life Sciences orEngineering

  • At least 3+years of experience in commissioning andqualification

  • Biopharmaceuticalknowledge andexperience

  • Specialisation ineither HVAC or CleanUtilities

  • Experience withDeltaV (Emerson) and other ControlSystems

  • Experience withCOMOS/KNEAT platforms

  • FluentEnglish language written and verbal communicationskills

  • cGMP knowledge andknowledge of regulatoryrequirements