Validation Engineer

  • Amsterdam
  • 3500.00 - 5500.00
  • 32-40 uren
  • HBO

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world.

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence. They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

functie Vereisten

  • At least a Bachelor’s (HBO) degree and 3 years working experience in a cGMP environment
  • A minimum of 2-3 years’ experience in commissioning and qualification within the Pharmaceutical, Biotechnology or Medical Device industry
  • Profound knowledge of Dutch and English language, has excellent verbal / written communication skills
  • Knowledge of Computerized Systems Validation is a plus
  • Computer fluency in MS Office, e.g. Office, Excel, Word. Knowledge of TrackWise is a plus
  • The ability to work with tight deadlines and to prioritize and handle multiple projects
  • You reside in and are eligible to work in The Netherlands (valid work permit)

Wat krijg je?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Werkzaamheden

The Validation Engineer (f/m/d) is mainly responsible for performance of Commissioning, Installation and Operational Qualification (IOQ), Performance Qualification (PQ), Periodic Validation Review (PVR) and Cleaning Validation studies in accordance with European and FDA cGMP, industry guidelines and Wacker Biotech policies and procedures.

  • Write, plan, organize, perform and report Commissioning, Installation & Operational Qualification (IOQ), Performance Qualification (PQ) validation studies and Periodic Validation Reviews (PVR) for equipment, utilities, facilities and processes
  • Design, execute and report Cleaning Validation studies for (multi-purpose) equipment according to international guidelines and internal quality policies
  • Actively participate within project teams as a key project team member for validation related activities
  • Coordinate, execute and/or supervise Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
  • Liaise with departmental representatives, as appropriate, to ensure validated status of equipment, utilities, facilities and processes
  • Keep abreast of industry developments in the field of validation and communicate as appropriate
  • Assess the impact on validated status and/or validation study validity on initiated deviations
  • Review and approve User Requirement Specifications to ensure validation requirements are fulfilled
  • Write, review and approve Impact Assessment Reports, Risk Assessments and FMEAs as needed

TAGCLOUD

Bas Lokhorst

Geïnteresseerd?

Stuur uw cv naar bas@tailorminds.com onder vermelding van vacature id (996)

Meer informatie?

Neem contact op met Bas Lokhorst van ons kantoor te Zoetermeer, te bereiken op nummer +31 6 82 43 66 08

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