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Sr. Commissioning & Validation specialist (GMP, FDA) - Oferta z Jobs.pl

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Sr. Commissioning & Validation specialist (GMP, FDA)

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  • Sr. Commissioning & Validation specialist (GMP, FDA)KEY WORDS: Validatie Manager, FDA, Audits, QMS, QA, QC, validation process, Operational excellence, opex, lean six sigma, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, project , pharma, Blackbelt, Microbiology, team work, Chemical engineering, medical science, downstream, upstream, utilitiesLocation:Amsterdam + travelling within EuropeType:PermanentStart date:As soon as possibleSalary range:90-100k per annumAbout the companyLeading Engineering company specialist in 350+ million Green- and Brownfield projects. Due to their growing activities in Europe in the pharmaceutical field, they're looking for experienced industry experts to join their team.Projects are done on a global scale for leading (bio)pharmaceutical companies.As a Senior Commissioning & validation engineer you will join a team of leading industry specialist, focussing on the commissioning, validation and qualification of pharmaceutical and biotechnology facilities.The responsibilities range (but are not limited to):•Leading and coordinating the validation and commissioning activities•Manage stand-alone validation projects and/or manage the validation and commissioning of major projects•Safeguard quality standards by initiating technical reviews and ensure compliance •Training of all involved personal and stakeholders•Provide technical expertise and guidance on cGMP guidelines•Regional and global stakeholder managementThe validation engineer must have a background or affinity with QA and experience with change control, as you're representing and promoting quality standards in the production environment. As this not a plant that produces API's, but medical nutrition the validation engineer must understand concepts behind validation and GMP regulations.Profile requirements•A proven track-record with multiple years in a similar role in the (bio)pharmaceutical sector. This is a position for an industry expert.•Able to lead complex validation and commissioning projects from pre-commissioning, handover, IQ/OQ/PQ and setting up Master Plans•Thorough experience in project management; able to calculate estimates and timeframes•Strong commercial sense•Deep knowledge on cGMP, FDA, requirements CFDA, EMEA, ISO regulations and ICH requirements•Experience working in large and complex projects•Thorough knowledge in change control processes•Full English and German proficiency •Willingness to travel extensively in Europe•You have strong analytical and strong conceptual thinking•BSc. + in relevant fieldInterested in this role? Then please don't hesitate to send your CV to Floris Peereboom at and I'll get in touch with you on a short time notice.Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.


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