Validation Engineer

Vor Ort
keine Angabe
7 months
Berry Technical
flag_no Schweiz

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Validation Engineer
Solothurn, Switzerland
Contract - until the end of 2013
85 CHF Per hour

Our client is looking for an experienced Validation engineer to join their team on site in Solothurn providing support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of our clients 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 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 the clients Validation Master List.
*Review and approve 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.

*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.
Individual must also be an active team member in Validation activities Methodology/Certification Requirements

Experience in Process Validation, Medical Devices, Mechanical and Chemical Processes, 21 FDA 820

Knowledge & Skills:
Required degree/certificates:
Junior Engineer or Technician

Specific technical skills (please detail):
21 FDA 820
ISO 13485

Good documentation practice

Specific languages:
German - good understanding/English fluent

Familiar with international dealing Companies (Matrix-Organization)

Please email.