Description
For our client in the pharmaceutical industry, we are looking for a
Verification Engineer Device Development (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: Basel Stadt
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Organize and conduct experimental characterization and cGMP Design Verification of medical devices/combination products
- Evaluation, practical development and validation of new test methods & technologies
- Organize and conduct method transfer to clinical/commercial sites
- Evaluation and implementation of new, state-of-the-art lab testing equipment (qualification, CSV)
- Translate/apply internal and external cGMP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) in practical lab processes (e.g., test method validation and transfer, discrepancy management and OOS, change management, complaints).
Your qualifications
- Technical education, BS or advanced degree in Engineering or Science discipline (pharmaceutical/natural/biomedical/materials science or a related field)
- Experience in practical testing of medical devices/combination products, primary packaging or pharmaceutical development (e.g., formulation, analytics), preferably for parenteral drug products
- Experience of working in pharma or other closely-regulated environment under cGxP, QSM or similar working practices
- Excellent knowledge of legislation, regulation, industry standards and guidance around the area of medical devices/combination products
- Demonstrable practical knowledge of the following: Statistical techniques, Lean six sigma, Root cause analysis, Risk assessment techniques, Method validation and transfer, Software for change/discrepancy management (e.g., Trackwise)
- Good knowledge of the following: Functional/physical testing (e.g., container closure integrity, compression/tensile testing, dimensional measurements); Jigs & fixture design; Parenteral drug delivery (e.g. s.c., i.v., i.m.); Equipment calibration, qualification, CSV; Analytical, data-driven thinking
- Very good command of spoken/written English and German
- Excellent documentation skills
Skills:
- Quality manager
- Qualification/validation specialist
Keywords: Technical education, BS, advanced degree, Engineering, Science, pharmaceutical, natural, biomedical, materials science, medical devices, combination products, primary packaging, pharmaceutical development, formulation, analytics, parenteral drug products, pharma, regulated environment, cGxP, QSM, legislation, regulation, statistical techniques, lean six sigma, root cause analysis, risk assessment, method validation, method transfer, Trackwise, container closure integrity, compression/tensile testing, dimensional measurements, Jigs & fixture design, Parenteral drug delivery, Equipment calibration, qualification, CSV, Analytical, data-driven thinking, English, German, documentation skills