Description
Validation Engineer CSV (f/m)We are looking for Validation Consultants in
- Canton Aargau
- Canton Basel-Landschaft
Your primary tasks and responsibilities
- 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.
- Update / compile process validation documents (Engineering Studies, IQ, OQ, PQ) and execute / follow these validations.
- 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
- Influences and persuades so as to bring about technical and process improvements.
- Managing Complexity/Technical Accountability
- Serves as technical expert for the Validation process and responsibilities to ensure compliance Continuous Learning/Managing Risk
- Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
- Update / compile URS (User Requirement Specifications) for the machine and modules of it.
Your profile:
- Minimum of 5 years working experience as Validation Consultant (CSV)
- Basic knowledge in statistics
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
- Language proficiencies: Fluent in English and German spoken and written.
Elena Reeb
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.