Validation Engineer (Test Method Validation) (m/f)

Solothurn  ‐ Onsite
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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
Start date
01/17
Duration
6 MM+
(extension possible)
From
Hays AG
Published at
15.12.2016
Contact person:
Kerstin Werner
Project ID:
1255843
Contract type
Freelance
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