Beschreibung
Equipment Validation Engineer - 6 months - Zurich - 85CHF p/h
Optimus Life Sciences are working with a globally respected Medical Device company based in Zurich. My client requires an Equipment Validation Engineer to validate test instruments and equipment.
Responsibilities
- Provide technical support for the validation group by interacting with end user's.
- Establish project timelines and expectations
- Ensure that operational execution is in compliance.
- Validate Test instruments and equipment.
- Provide technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems.
- Support Validation management by interacting with regulatory authorities during site inspections relative to facility and equipment cGMP areas; supports successful management of inspections
Requirements
- Working knowledge of validation test instruments and equipment.
- At least 4 years' experience of validation of a large number of GxP systems and sterilization processes.
- Proven knowledge on validation of a large number of GxP systems and sterilisation processes.
- Extensive knowledge of 21CFR11 requirements.
- GxP experience