What are your responsibilities?
As Engineering Systems Specialist, you are in charge to
Create and improve the templates of engineering documentation including validation documentation
Create and improve engineering guidance to standardize the flow of the documentation and the validation requirements
Coordinate and Improve the structure engineering documentation repertory
Coach partners of the engineering team to improve their documentation aspect
Write / Review project documentation drafted by engineers before the official validation review
Support engineering team for new projects according to GMP and Best Engineering Practices requirements
Support mechanical and automation engineering projects documentations (URS, Functional & design specifications, commissioning activities )
Create and improve templates & guidances for Site Engineering activities (tenders, validation packages, ...)
Support the redaction, coach engineers and review of documentations before Validation Agreement.
Recommend efficient improvement to qualify equipments and systems.
Coordinate engineering documentation activities to support the projects
Improve the department documentation structure.
Periodic review of Engineering procedures and forms to ensure alignment with local / divisional procedures
Assure strict compliance with cGMP, 21 CFRs, GAMP5, Corporate, Divisional and regulatory requirements
Support site activities as a technical professional to facilitate investigations
Who are you?
You are graduated as a Master degree in Biology, Validation, Mechanics, Electrics or Automation . You have an experience in pharmaceutical industry and knowledges in GMP and FDA .
You have 5 years as Validation Engineer. You demonstrate ability with the technology evolution for automation systems. You have good written and verbal skills in French and English.
What can you expect?
A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.
You're interested in this job? We kindly invite you to apply directly on our website www.experis.be. Do you have questions?
You can contact or 0478 / 90.63.68.