Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Senior Verification Engineer, Device Development, Biologics
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Engineering, Design, Engineer
Projektbeschreibung
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
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
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Ingenieurwesen/Technik