Description
We are looking for a
Validation Engineer (Test Method Validation) (m/f)
Reference: -en
Start: 01/17
Duration: 6 MM+
Place: in the Solothurn region
Branch: Medizintechnik
Your tasks:
- Originate test method assessment, including protocol and plan for outlined CCPs or other control points
- Coordinate required actions and assure that test method validations are completed on time
- Origination and approval of TMV, including determination of sample size and worst case parts
- Draft and review job breakdown sheets, including conduction 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
Your qualifications
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification) with a broad technical/educational skills base
- Knowledge of bespoke validation and processes
- Ability to write technical documentation (work instructions, risk assessment and plan etc.)
- In-depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry desirable
- High understanding of GMP, compliance, validation practices, including the system development life cycle and Regulatory expectations
- Working experience with regard to validation computer systems for use in a FDA regulated environment, fluency in English and German
Skills:
- Qualification/validation specialist