CQV Engineer - Visp, Schweiz - Randstad

Beschreibung

Jobdescription
For ourclient, an international company in Visp, we are looking fora CQV Engineer.

The CQV Engineer isprimarily responsible for the preparation and the execution of theCQV activities as per below responsibilities.

GeneralInformation:

• Start date:ASAP
• Latest start date: October2024
• Contract duration: 1year
• Workplace:Visp
• Workload: 100%
• Homeoffice: not possible

Responsibilities ((includes but is not limited to):

• Execution of the followingactivities for the relevant systems in accordance with Vibe-XProject procedures/guidelines:
  • System Boundarydevelopment + approval.
  • Design Qualificationpreparation, execution and approval. Includes release forIQ.
  • GMP-RA's.
  • Commissioningpreparation, execution and approval. Includes vendor supervision ontheir testing scope and quality.
  • InstallationQualification preparation, execution and approval. Includes releasefor OQ.
  • Operational Qualification preparation,execution and approval. Includes release toOPS.
• Provide support inexecution of Design Qualification for other direct impactsystems.
• Provide support in the implementationof the Installation Commissioning process in accordance withProject procedures/guidelines.
• Shall be able towork / support another C&Q activity if deemednecessary.
• Carry out shift work, whererequired.
• Available for travel to vendors /contractors, were required.

SystemResponsibilities:

The list of the systemsfor which the CQV Engineer is responsible, depends on the assignedequipment group and will be shared with the holder of the positionat job start. The equipment group for which the candidate will getassigned to, will be evaluated during the interview and will becommunicated to the candidate with the job offer. The system scopefor which the CQV Engineer will be responsible may evolve over timeand may gets updated as the project progresses.

Your Profile:

• Minimum Bachelor's degree in LifeSciences or Engineering
• Minimum of 2+ years ofexperience in commissioning / qualification / validation (DQ, IQ,OQ, Commissioning) activities in the pharmaceutical/biotechindustry.
• Proven Process or Utility Equipmentexperience (either DSP, USP, Bioconjugates or CleanUtilities)
• Minimum 2+ years of experience incommissioning / qualification / validation of Clean UtilitiesSystems.
• Experience with DeltaV(Emerson).
• Fluent English language written andverbal communication skills.
• cGMP knowledge andknowledge of regulatory requirements.
• Able towork with minimum oversight fulfilling deliverables within targetdates.

Nice tohave:

• FluentGerman
• Experience with COMOS/KNEATplatforms