Beschreibung
For your Medical Devices client in Switzerland, we are urgently seeking a Validation Engineer with good experience in CSV.
Job title: Validation Engineer
Duration of contract: 6 months
Location: Solothurn, Switzerland
Language: Fluent in German and English
Your role:
- Originate and approval of Test Method Validations including of determination of sample size and worst case parts
- Draft and review Job Breakdown Sheets including conducting of 4-Step Method training
- Establish adequate documentation for CAPA action
- Conduct transfers of TMV protocols and plans Originate requested documents for validation and computer system validation with support of Subject Matter Experts
- Coordinate actions and assure that deliverables are completed on time Serves as technical expert for the Validation process and responsibilities to ensure compliance
- 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
- 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.
- 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
Your experience:
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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.