Validation Engineer CSV (f/m)

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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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T: +41 (0) 44 588 2619

E: e.reeb(at)realstaffing.com

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.