Connecting...

Validation Project Engineer

Technical expertise:

  1. You provide technical input in the project team for your own discipline. You have the technical and operational knowledge of how the installation or system functions and understand the internal requirements (operational/technical/compliance).
  2. You are responsible for the design of the equipment, building, utility or process automatization system.
  3. You define and document the technical specs and reviews with the relevant SME.
  4. You follow the engineering standards and aligns with the Lead Engineer during design, construction and implementation.
  5. You follow up the construction, implementation and functioning of the equipment, building, utility or process automatization system to guarantee the installation is according to specifications.

Project management:

  1. You make the regular reporting of progress to Project Leader or subteamlead.
  2. You guarantee good Project Management practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, etc.) for own equipment/installation/scope.
  3. You assure timely escalation of issues to Project Leader or subteamlead.
  4. You keep oversight of the contractor company that will build, install or test the equipment/installation.
  5. You provide governance of contractors on a construction site, you are responsible for the safety on the construction site and follow all safety systems as indicated in the contractor safety file.
  6. You are responsible for transfer to operations of your own equipment/installation/scope, delivering all project documentation and close out of the project.
  7. You also ensure a follow-up of start up results to guarantee that the project deliverables were achieved.

Documentation, validation and regulatory aspects:

  1. You assure correct documentation of design, construction and verification/validation on the engineering project folder.
  2. You are responsible for following the procurement process for own equipment/installation/scope.
  3. You are responsible for the creation and follow up of the required change notifications/CRF.
  4. You are responsible for defining and executing the engineering tests, verification and validation of own equipment, building or utility. You define the validation approach, create test protocols for engineering tests, create verification and validation documents, executes tests, coordinates SME and system owner approvals.
  5. You are responsible to solve and document deviations and actions (CAPA's, risk assessments, CGMP review, new document versions).
  6. You support other validations executed by other departments.
  7. You will support the registration process in relation with site compliance if required.

Your profile:

  • You have a Master degree as Industrial Engineer, Civil Engineer, Bio-Engineer or equivalent due to experience.
  • You have at least 4 years of relevant experience in the pharmaceutical industry.
  • You are a driven teamplayer who can also work independentely.
  • You have strong organisational and documentation skills.
  • You have an open and clear communication.
  • You have a technical background.