Verification Engineer in Basel

veröffentlicht
Kontakt
Dominik Udovicic, Zürich Professionals IT
Jobtyp
temporär
Jetzt bewerben

job details

veröffentlicht
Ort
Basel, Basel-Stadt
Sektor
Gesundheitswesen
Jobtyp
temporär
Referenznummer
9713
Kontakt
Dominik Udovicic, Zürich Professionals IT
Telefon
058 201 56 60
Jetzt bewerben

Stellenbeschreibung

Verification Engineer

For one of our client, a well known pharma company, we are looking for a Verification Engineer who is responsible to Translate cGxP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) into practical lab processes (e.g. test sample management, test method validation and transfer, discrepancy management and OOS, training, change management, complaints) including practica development, implementation, documentation.

Duties: 

  • Develop robust test method validations
  • Perform Risk Assessment / FMEA
  • Define appropriate statistical techniques and acceptance criteria
  • Author of protocols, rationales and reports
  • Lead or support transfer of methods into clinical and commercial facilities/packaging centers
  • Lead and track Change Control activities for Test Methods and Lab Processes, Assess impact of changes (internal or external) on test method validation and compliance of existing lab processes.
  • Support management during internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses
  • Support the development and completion of robust, risk-based, medical devices / combination products verification strategies.
  • Facilitate planning and execution of early experimental testing (DoE)
    • Write, review, approve design verification plans, protocols and reports, support development of rationales justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
    • Analyze test data (design capability, trending, k-value)
    • Lead and track management of unexpected events (e.g., discrepancies, complaints) for these medical devices/combination products within cGxP regulated area

Technical Requirements:

  • Technical/Engineering degree education, with additional Statistical qualification (or equivalent experience).
  • (Bachelor, Master or PhD in Engineering or Science discipline (pharmaceutical/ natural/biomedical/materials science or a related field)
  • Process oriented and analytical thinking (sensibilisation to lean 6s techniques highly desirable)
  • 2-5 year track record and experience in (statistic) and characterization of medical device/combination products, special/innovative packaging, or compact, complex, multi-material hand-held products
  • Experience of working in Pharma or Medical Device (cGxP, QSR) or other closely- regulated environment
  • Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices Demonstrable practical knowledge of the following:
    • Common Statistical Tools and Techniques (Descriptive Statistics, Hypothesis Testing)
    • Measurement System Analysis (Gage R&R), Capability Analysis (Cpk, k-value)
    • Root Cause Analysis
    • Risk Assessment techniques
    • Method or Process Validation and Transfers
    • Software for Statistic and Change/Discrepancy Management (e.g. Minitab, TrackWise)
    • Excellent command of spoken/written German and English
    • Excellent documentation skills

If your profile matches the requirements above, we are looking to receive your application.