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Brunel

Equipment qualification engineer

VC439006 SVDL

Via Brunel

Published on Jobat.be 12 days ago

Dou you have experience with validation of equipment?

Check out this vacancy!

Equipment qualification engineer

Job description

Equipment Qualification Engineers:

Tasks:

  • Is responsible to create and follow up the required change notifications/CRF
  • Is resposible for defining and executing the engineering tests, verification and validation  of assigned equipment.  Defines the validation approach, creates test protocols for engineering tests, creates verification and validation documents, executes tests, coördinates SME and system owner approvals. Is responsible to solve and document deviations and actions (CAPA’s, risk assessments, CGMP review, new document versions)
  • Supports other validations (ECO, SMC, batch records) executed by other departments
  • As responsible for the CRF, the PE will support the registration process in relation with site compliance if required
  • Supports documentation of technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams) and reviews with the relevant PE/SME

Profile

  • Good documentation skills, able to deliver clear and complete documents
  • Good communication skills
  • Pragmatic, pro-active, can take the lead
  • Results focussed
  • Able to work independently but is also a teamplayer
  • Experienced in planning and project coordination (MS Project is a plus)
  • Quality minded – experience in pharma (GMP, risk assessments, verification & validation)
  • Hands-on and good problem solving skills
  • Shows ownership

Offer

  • An interesting salary package
  • A dynamic and high-tech life sciences environment
Mechelen - Lier

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Learn about Brunel?

Brunel

Blarenberglaan 3, 2800 Mechelen

Routebeschrijving
Grotere kaart weergeven
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48 days left to apply

Characteristics

Requirements

  • Professional bachelor (Higher Education Short Type)
  • At least 2 years experience
  • English

Offer

  • Permanent
  • Full-time

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