Process Validation Engineer

For a project for our client in Solothurn we are looking for a

PROCESS VALIDATION ENGINEER- Fluent German is a MUST for this position

Tasks:

- Managing Complexity/Technical Accountability/Continuous Learning/Managing Risk.
- Serves as technical expert for the Validation process and responsibilities to ensure compliance.
- Resolves & manages technical operational problems in area of expertise.
- Suggest and implement innovation and continuous improvement within the Validation process.
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness.
- Ensure accuracy and maintenance of the company 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.
- Develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with company Policies and Procedures.
- 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.

Technical Requirements:

- Fluent German and English is an absolute MUST
- Knowledge of bespoke validation.
- Process knowledge and documentation.
- 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.
- 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 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.

Are you interested in this position? Then we are looking forward to receiving your application.