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Brunel

Equipment qualification engineers

VC439843 SVDL

Via Brunel

Published on Jobat.be 6 days ago

  • For the moment one of our clients is looking for several qualification engineers with experience in:
  • C&Q of automatic inspection equipment for semi-finished product (particles, cosmetic defects, fill volume, leak testing)
  • Moving and requalification of inspection (or packaging) equipment
  • C&Q of Freeze Dry equipment 
  • C&Q of ALUS systems (automatic loading & unloading of freeze dryers) 
  • Candidates with C&Q experience of preparation equipment (autoclaves, washers, …) or other equipment will also be reviewed

Equipment qualification engineers

Job description

  • Create and follow up the required change notifications/CRF
  • 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 project engineer 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

  • We are looking for someone who:
  •  Has good documentation skills
  • Is able to deliver clear and complete documents
  • Has good communication skills
  • Is pragmatic, pro-active and can take the lead
  • Has experienced in planning and project coordination (MS Project is a plus)
  • Is quality minded – experience in pharma (GMP, risk assessments, verification & validation)

 

Offer

  • We are always looking for new talents who fit in our Brunel team and who match with our clients need for specialized support 
  • We offer an interesting salary package and job opportunities in dynamic high-tech life sciences environments 
  • Become a member of our Brunel Crew and we will help you fulfill your career ambitions
Mechelen - Lier

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Learn about Brunel?

Brunel

Blarenberglaan 3, 2800 Mechelen

Routebeschrijving
Grotere kaart weergeven
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54 days left to apply

Characteristics

Requirements

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

Offer

  • Freelance
  • Permanent
  • Full-time

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