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Validation Engineer (Medical Device Sector)
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineer, Engineering, Support
Projektbeschreibung
For a 3 month position at 60%, we are looking ASAP for a Validation Engineer. This position would be based in Mezzovico.
Position: Validation Engineer
Place of work: Mezzovico
Beginning of employment: 16.05.2016
End of employment: 05.08.2016
Workload: 60%/25 hours
Validation Engineer To provide support for the validation activities associated with software equipment, ensuring that all compliance issues and requirements of company Validation Policies and Procedures are addressed.
Justification for Request: To support the CSV activities in the project "Purified Water System" at the Mezzovico site.
Primary Tasks and Responsibilities:
- Managing Complexity/Technical Accountability
- Serves as technical expert for the Validation process and responsibilities to ensure compliance
- Continuous Learning/Managing Risk.
- Resolves & manages technical operational problems in area of expertise.
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process.
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas.
- Manages relationships externally and internally.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness.
- Fosters harmony within Quality Systems.
- Influences and persuades so as to bring about technical and process improvements.
- Ensure accuracy and maintenance of company Validation Master List.
Technical Profile Requirements:
- Knowledge of bespoke validation.
- Process knowledge and documentation.
-In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.
Methodology/Certification Requirements:
Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base.
- Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.
Desirable:
- A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience.
- Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
Position: Validation Engineer
Place of work: Mezzovico
Beginning of employment: 16.05.2016
End of employment: 05.08.2016
Workload: 60%/25 hours
Validation Engineer To provide support for the validation activities associated with software equipment, ensuring that all compliance issues and requirements of company Validation Policies and Procedures are addressed.
Justification for Request: To support the CSV activities in the project "Purified Water System" at the Mezzovico site.
Primary Tasks and Responsibilities:
- Managing Complexity/Technical Accountability
- Serves as technical expert for the Validation process and responsibilities to ensure compliance
- Continuous Learning/Managing Risk.
- Resolves & manages technical operational problems in area of expertise.
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process.
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas.
- Manages relationships externally and internally.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness.
- Fosters harmony within Quality Systems.
- Influences and persuades so as to bring about technical and process improvements.
- Ensure accuracy and maintenance of company Validation Master List.
Technical Profile Requirements:
- Knowledge of bespoke validation.
- Process knowledge and documentation.
-In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.
Methodology/Certification Requirements:
Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base.
- Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.
Desirable:
- A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience.
- Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges