Engineer Systems Specialist
- Durée indéterminée, Temps plein
Engineer Systems Specialist
Hainaut - CDI
#validation #engineering #documentation #pharma #GMP #improvment #mecahnical #automation
Are you interested in the pharmaceutical industry and putting your knowledge of validation system to good use?
Our client is actively looking for an Engineering Systems Specialist to strengthen its activities. Our partner is active in the pharmaceutical sector.
Description de la fonction
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
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.
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.
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- Master (Licence, Université ou Enseignement Supérieur de Type Long)
- Durée indéterminée
- Temps plein
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- 6 décembre
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