Validation Engineer

  • Groningen
  • 4500.00 - 5500.00
  • 32-40 hours
  • Bachelor degree

Client

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

Client

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.

Requirements

Required:
  • Minimal 5 years experience with Computer System Validation (CSV)
  • Able to give team guidance.
  • Perform general validation activities (equipment validation also).
  • Experience with GMP (preferably GAMP5), validating (automated) equipment and the implementation and documentation thereof.
  • Be able to work independently as much as possible as soon as possible.
  • Follow and keep up-to-date the required training courses in a timely manner.
  • Affinity with quality environments (QA).

Desired/Pre:
  • Experience with GAMP5, ISO-13485, CFR21, MDR.
  • Experience in medical device industry.
  • Good written and oral English skills, Dutch is an advantage.
  • Software: Jira, X-Ray, Minitab.

What do you get?

  • 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

Duties

  • Drafting and performing validations.
  • Drawing up requirement specifications and/or user stories.
  • Creating and executing test protocols.
  • Written report of protocol execution.
  • Where applicable, electronic reporting of protocol export.
  • Handling deviations and/or defects and communication with Validation Review Board.

TAGCLOUD

CSV
#engineer
#medicaldevices
#GAMP
#CFR21
#validation
#equipment
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1114)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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