Beschreibung
Senior Verification Engineer, PTDE-D Device Development, Biologics
Verification Engineering Group Responsibilities:
Evaluation, characterization, verification and complaint investigation of medical devices for combination products (eg, pre-fillable syringe, needle safety device, autoinjector, injector pen, patch injector, new technology, special primary packaging)
Senior Verification Engineer Responsibilities:
- Investigational evaluation of competitor and innovative technologies
- Generation of investigational Technical Reports
- Implementation, calibration and qualification/validation of test equipment
- Development, evaluation, validation of physical measurement and test methods for Verification and QC
- Involvement in delivery device design' and system' Risk Assessments
- Risk-driven setting of test sample size, Data-driven establishment of acceptance criteria
- Generation of Test Plans, Test Protocols, Test Reports
- Organise and co-ordinate experimental, development, Verification, complaint investigation and change evaluation testing
- Statistical analysis of test data, interpretation of outcomes, review and approval of Test and Technical Reports, consolidation and analysis of historical data
- Process capability assessment
- Liaison with; and provide technical support to; key customers in clinical and commercial phases - such as filling, assembly and packaging operations, packaging and quality groups, regulatory, process and formulation development groups, supply chain
- Support to Technology Transfer of combination products and medical devices into commercial facilities/packaging centers (specification/method/equipment transfer)
Requirements:
- Technical education, preferably with an engineering degree
- 2-5 year track record and experience in Quality Engineering, Design Verification, characterisation of medical devices, special/innovative packaging, or other compact, complex, multi-material hand-held products
- Experience of working in pharma or other closely-regulated environment, under cGxP, QSR or similar working practices
- Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices
- Demonstrable practical knowledge of the following;
o Drug container integrity
o Parenteral drug delivery (eg: sub-cutaneous, intra-venous, intra-muscular, transdermal)
o Statistical Techniques and Six Sigma principles
o Jigs and Fixtures design, Instrument Calibration, Equipment qualification
o Functional testing and reliability
o Medical device risk management process
o Secondary packaging
o Transport studies and validation
o Inspection methods and techniques
- Excellent command of spoken/written English, German an advantage
- Excellent documentation skills
- Excellent team player, with collaborative and oral/interpersonal/communication skills
- Excellent IT knowledge