Validation Engineer - Italian Speaking - Ticino, Switzerland

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6 months
Von:
Templeton and Partners
Ort:
Ticino
Eingestellt:
14.05.2013
Land:
flag_no Schweiz
Projekt-ID:
535794

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Validation Engineer - Italian Speaking - Ticino, Switzerland

Technical Profile Requirements
Knowledge of bespoke validation.
Process knowledge and documentation.

Desirable:
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.

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

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.

Language Skills: English & Italian fluent

Validation Engineer to provide support for the validation activities associated with equipment and business applications ensuring that all compliance issues and requirements of the client. Validation Policies and Procedures are addressed.

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 behavior 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 the client Validation Master List.
Create Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
Ensure that all validation activities are carried out and reported in a timely manner.
Ensure compliance through assisting in audits.
Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with client Policies and Procedures.
Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
Keep management informed 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
Lead by example, inculcating the Credo values in all actions within the workplace