Validation Engineer m/f

Validation Engineer m/fTasks:

- 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
- Ensure accuracy and maintenance
- Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations
- 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.Your Profile:
- 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
- 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 a broad technical/educational skills baseOthers:

Location: Solothurn

Start date: ASAP

End date: 30.09.2014 (extension possible)

Hourly rate: negotiableContact:

Alexander Berk

ACCOUNT MANAGER PHARMACEUTICAL

Michael Bailey International is acting as an Employment Business in relation to this vacancy.