17 days ago
My client, a privately owned global pharma are looking for a CQV Engineer.
Title: Qualification and Validation Engineer
Location: Lower Saxony
- Optimization of the system qualifications & cleaning validations with regard to official requirements especially FDA
- Participation in the planning & evaluation of process performance qualifications (PPQ)
- Project planning for changes and extensions to the production area
- Examination and harmonization of qualification and validation concepts with regard to FDA requirements
- Drafting the relevant documents (plans, reports, SOPs, etc.)
- Participation in answering inquiries from authorities and participating in audits and inspections
- Study of engineering or natural sciences
- Several years of professional experience in an FDA-regulated pharmaceutical company (focus: qualification / validation, Production or quality assurance)
- Very good knowledge of relevant standards & laws (GMP and FDA)
- Secure IT skills (MS Office, MS Project, MS Visio)
- very good knowledge of English
- Structured & precise way of working as well as organizational & communication skills
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