Description
VALIDATION ENGINEERMEDICAL DEVICE
to
One is located in the Italian-speaking part of Switzerland, close to lovely LUGANO
One is located in the German-speaking part of Switzerland Close to the nice City SOLOTHURN
Please find the Job description, which applies for both roles,below:
A Validation Engineer contractor is required to provide support for:
* Validation activities associated with Functional and Physical test methods ensuring that all compliance issues and requirements of internal Method Validation Policies and Procedures are addressed. Primary Tasks and
Responsibilities:
* Serve as the technical expert for the Test Method Validation process to ensure compliance
* Continuous Learning/Managing Risk
* Resolving technical operational problems in areas of expertise
* Suggest innovative and continuous improvement ideas within the Test Method Validation processes
* Influence and persuade others to make technical and process improvements.
* Create the Test Method Validation Master List.
* Write and review Validation Master Plans, Test Method Procedures, Protocols, Summary Reports and other documentation associated with Test Method Validations, as appropriate for each validation exercise.
* Serve as a member of a team of experts to identify the worst cases and establish a bracketing approach to remediate the Test Method Validations in place.
* Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
* Inform Management of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Profile:
* Expert knowledge of Functional and Physical Test Method Validation.
* Manufacturing and Medical Device production process knowledge.
* In depth knowledge of 21 CF 820, 21 CF 11 and European regulations associated with the medical device industry (ISO 13485, ISO 9001 and technical norms related to validation), knowledge of HF.
* High understanding of GIMP, GDP, GP, Compliance, Validation Practises including the system development life cycle and Regulatory expectations.
* Working experience of validation and test method validations for use in a FDA regulated environment.
* Knowledge of process statistics (desirable Six Sigma Green Belt or higher certification)
* Knowledge of MAS for mechanical industries, metro logy and calibration for highly regulated environments Desirable:
* A degree in an appropriate discipline (e.g. Engineering, life-science, natural sciences) with a broad technical/educational skill base and substantial related experience
* Minimum of 2 - 5 years working in a regulated industry including 2 of which has been spent carrying out validations.
Non-Technical Profile Requirements:
* Must be able to lead and give direction to Validation Projects and Teams.
* Individual must also be an active team member in Validation activities
* Must be independent, result oriented and have a problem-solving attitude
* Proficient user of both written and spoken English (mandatory), German is also desirable
* Good precision and ability to create ordered and compliant reports
If you are interesting to receive more Information regarding those positions, please do not hesitate to get in contact with me on your earliest convenience.
I am looking Forward to hear from you.
Greetings from Zürich!
S.Keel