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Project Engineer Filling

Project Engineer Filling

ArcadisPuurs, Flemish Region, Belgium
16 dagen geleden
Functieomschrijving

A Project Engineer with technical expertise preferably in one of the following : filling equipment for process technologies related to pharmaceutical filling processes; experience with testing, verification and validation of filling equipment within sterile environment is a plus. Responsible for project engineering activities related to specific technology, equipment or process installation (filling equipment : filling lines, isolators, e-beams, washers, tunnels and / or cappers).

  • Provides technical input in the project team for own discipline. Has technical and operational knowledge and expertise
  • Knows how the installation or system functions and knows the internal requirements (operational / technical / compliance)
  • Defines and documents the technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams) and reviews with the relevant SME
  • Follows the engineering standards and aligns with the lead engineer during design, construction and implementation
  • Follows up the construction, implementation and functioning of the equipment to guarantee the installation is according to spec
  • Guarantees good project management practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, …) for own equipment / installation / scope
  • Keeps oversight of the contractor company that will build, install or test the equipment
  • Is responsible for transfer to operations of own equipment, delivering all project documentation and close out of the project
  • Follows start up results to guarantee that the project deliverables were achieved
  • Assures correct documentation of construction and verification / validation on the engineering project folder. Is responsible for defining and executing the engineering tests, verification and validation of own equipment
  • Defines the validation approach, creates test protocols for engineering tests, creates verification and validation documents, executes tests, coordinates SME and system owner approvals
  • PE is responsible to solve and document deviations and actions (CAPA’s, risk assessments, cGMP review, new document versions)

Experience :

  • Experience in a pharmaceutical environment and / or GMP in an aseptic environment is a big plus
  • Experience in validation is a big plus
  • Affinity with the pharma sector is a must
  • Project coordination / contractor management is a plus
  • Technical / scientific Master is a must : industrial, civil or bio engineer is a must
  • Strong communication skills
  • Strong organizational skills
  • Team player
  • Analytical
  • Punctual, pro-active
  • Can work independently
  • Assertive
  • High interest in technical / technological and process related aspects
  • Can handle frequent changes in project / environment
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