LEAD VALIDATION ENGINEER

Neder-over-HeenbekIFarmaceutische industrie

FunctieomschrijvingObjectives: 
As Lead Engineering, you define, coordinate and guide the overall qualification and validation strategy and processes according to the project specifications, in collaboration with the project team and internal and external stakeholders. 
You are the link between Engineering, Qualification, Validation and QA. 

Responsibilities: 
  • You will ensure correct, point accurate qualification and validation processes, establish the validation plan and be responsible for all cGMP decisions made during the validation of the investment project, from design to the preparation of the summary validation report. 
  • You oversee the qualification processes (IQ, OQ, PQ) and validation activities (PPQ, CV, PV). 
  • You are responsible for writing, checking and approving qualification documents (risk assessment, qualification protocols and reports, ...). 
  • You are responsible for the coordination of the qualification activities to be carried out. 
  • You are responsible for the implementation of the system validation guidelines and standard procedure for the processes and devices (validation life cycle, qualifications). 
  • You are responsible for the implementation of a sound system validation strategy, compliant with FDA, EMA and international quality standards. 
  • You make sure that everything is ready for inspection - cf. system validation. 
  • You will assist with the requirements for equivalence reports, Equipment Family reports, etc. 

Profiel Profile:
  • You have a master degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or another relevant direction. 
  • You have at least 5 years of experience in a pharmaceutical production environment, process validation and equipment validation. 
  • You are an expert in qualification and validation activities, control tests, cGMP and EMA/FDA. 
  • You understand best practice in biopharmaceuticals. 
  • Experience in document writing and auditing is important and a real asset. 
  • You will quickly understand the characteristics and functioning of a wide range of production equipment and processes, as well as their potential impact on product and patient safety. 
  • You will use a risk based approach to solve problems and prioritize tasks. 
  • You ensure quality and compliance in technical and qualification activities. 
  • You are a good communicator with strong organisational skills and persuasiveness. Thanks to these qualities you will be able to work smoothly together with different departments. 
  • You can work independently with minimal supervision and plan tasks in time to deliver the project on time. 
  • You are a real team player and work well together to make the validation project a success. 
  • You are fluent in English, Dutch and/or French. 

Organisatie- en afdelingomschrijvingSelect Projects maakt deel uit van een internationale full-service Human Resources-organisatie, Select HR. Select Projects is specialist in het aanbieden van oplossingen via projectsourcing. Vanuit onze vestigingen in België en Dubai bieden wij ondersteuning aan bedrijven die behoefte hebben aan ervaren specialisten/projectmedewerkers in verscheidene werkgebieden. We onderscheiden ons door onze goede opvolging en service naar al onze klanten en onze medewerkers.

Voor één van onze pharma klanten in regio Brussel zijn wij op zoek naar een QUALITY ENGINEER (M/V).Aanbod You will receive an attractive salary package with interesting extra-legal benefits (company car, hospitalisation insurance, group insurance, meal vouchers, etc.). All this in an exciting pharmaceutical and international work environment where you have plenty of opportunities to develop yourself.
Heb je nog vragen?
Valérie François Select Projects 0491 86 99 81
LEAD VALIDATION ENGINEER Vacature informatie
85659
Biowetenschappen
Project sourcing
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