VALIDATION COMPLIANCE ENGINEER

GeelIFarmaceutische industrie I Engineering

Functieomschrijving

As Validation Compliance Engineer you are responsible for: 

  • Will report to the project’s Validation & Compliance Lead.
  • Validation / Compliance Review of Hardware Acceptance Testing, Site Installation Testing, Software / Functional Acceptance Testing, automation Commissioning & Qualification (IQ, OQ, PQ) protocols & test forms to support the execution of those test stages.
  • Facilitation of Impact Assessments, Risk Assessments, Design Review, Requirements Traceability Matrices as well as the Validation / Compliance Review of these, hereby engaging with Operations, Technical Operations, Software, Equipment, Validation and QA SME’s / project team members.
  • Deviation / change management review.
Profiel
  • Degree in Engineering preferred.
  • Pharma experience preferred.
  • Has good interpersonal and communication skills.
  • Has good teamworking skills.
  • Can demonstrate a pro-active behavior, seeing potential issues / risks / opportunities and translate these into mitigations / solutions / improvements.
  • Can work well under pressure.
  • Relevant technical expertise preferred (DCS systems, preferable Emerson DeltaV ; Batch Control ; ISA S88).
  • Knowledge on GAMP 5.
  • Has GDP/GMP experience and mindset!
  • Fluent in Dutch with good knowledge of English (speaking, reading, writing).
  • Has experience with Compliance related tasks with regards to Hardware Acceptance Testing, Site Installation Testing, Software Acceptance Testing, Commissioning & Qualification (IQ, OQ, PQ) related to (pharm) equipment & processes, E&I and DCS.
  • Has experience throughout the validation lifecycle from requirements to retirement.
Organisatie- en afdelingomschrijving

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, The Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Heb je nog vragen?
Aartje Huybrechts Select Antwerpen +32 3 612 22 92
VALIDATION COMPLIANCE ENGINEER Vacature informatie
62578
Engineering / Techniek
40
Wat is mijn reistijd?

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