Beschreibung
Task:Focus: Test Method Validation / Validation Engineer
- provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods
- and environment ensuring that all compliance issues and requirements
- Managing Complexity/Technical Accountability
- Serves as technical expert for the Validation process and responsibilities to ensure compliance
- Continuous Learning/Managing Risk
- 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
- Builds cross-functional and cross-departmental support, fostering overall effectiveness
- Fosters harmony within Quality Systems.
Requirements (Must have):
- Knowledge of bespoke validation
- Process knowledge and documentation
- 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
- active team member in Validation activities Methodology/Certification Requirements
- A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification)
- Minimum of 2 - 5 years working in a regulated industry
- a minimum 2 of which has been spent carrying out validations and/or testing activities
- English and German Speaking
Environment/Miscellaneous:
- Fulltime
Beginn: 01.04.2016
Dauer: 31.05.2016
Branche: Medizin/Healthcare