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Brunel

Equipment qualification engineer

Puurs - België - Life sciences - Pharmacie - Project Management & Services - Academic Master

Brunel | Mechelen | Permanent, Full-time

Published on Jobat.be 6 days ago

Do you have experience with packaging equipment or other equipment?

Check out this vacancy !

Equipment qualification engineer

Job description

Tasks:

  • Is responsible to create and follow up the required change notifications/CRF.
  • Is responsible 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, coordinates 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 focused
  • Able to work independently but is also a team player
  • 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

Interested?

Sophie Steels
Mechelen

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Brunel

Blarenberglaan 3, 2800 Mechelen

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28 days left to apply

Characteristics

Offer

  • Permanent
  • Full-time

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