Validation Engineer Packaging

  • Noord-Brabant
  • 4000.00 - 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

  • Experienced with Secondary Packaging Systems, including experience with Print and Inspection systems (e.g. Systech, Cognex)
  • At least 5 years’ experience in executing Commissioning, Qualification and Validation within manufacturing organizations in the pharmaceutical industries.
  • Experienced in Computerized Systems Validation
  • Basic knowledge of Paperless validation systems (HP ALM/ KNEAT)
  • Hands on commissioning and qualification experience within Secondary Packaging Operations.
  • Good understanding of the role of a single document within the bigger picture.
  • Internal and /or external reporting relationships.
  • Ability to work independently and remotely with minimum direct supervision
  • Good English Technical Writing Skills
  • Customer relationship management skills
  • Critical thinking skills
  • Able to set clear priorities and escalate to ensure timely delivery of the project phases including design, development, implementation, testing, construction, commissioning, and validation.
  • Experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling.
  • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise.

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 CQV Engineer will support technical projects under minimal supervision and will report to Validation Manager of Site engineering. The CQV Engineer will demonstrate hands on commissioning/qualification skills, including but not limited to the following: develop, implement and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures. The CQV Engineer will drive the development of system commissioning qualification and validation documentation.

Key Responsibilities:
  • System Level Criticality Assessments
  • Commissioning, Qualification and Validation plans
  • Risk assessments
  • Protocols and reports
  • Requirement traceability matrices
  • Commissioning, Qualification and Validation summary reports
  • Lead Commissioning, Qualification and Validation testing activities
  • Deliver guidance to the project group, so the implement technical solution follows the validation plan in order to achieve meeting internal customer requirements, and accordance with SOP's

TAGCLOUD

Sander Pupella

Geïnteresseerd?

Stuur uw cv naar sander@tailorminds.com onder vermelding van vacature id (1211)

Meer informatie?

Neem contact op met Sander Pupella van ons kantoor te Zoetermeer, te bereiken op nummer +31 6-13140754

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