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Validation Engineer

Validation Engineer

Job Title: Validation Engineer
Contract Type: Permanent
Location: Bern, Switzerland
Industry:
Salary: Negotiable
Reference: ID128076_1593012016
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: June 24, 2020 16:20

Job Description

Wir unterstützen unseren Schweizer Partner dabei für einen Schweizer Kunden einen Projektleiter zu suchen!

Our Client:

An award winning and fast growing medical technology company.

Job description:

  • Create and maintain the site Master Validation Plan
  • Development of validation protocols (IQ, OQ, PQ)
  • Collate all data associated with a validation (IQ, OQ, PQ) and compile the final validation report for approval
  • Maintain all validation documentation in accordance with site Quality System Requirements
  • Verify that that validation studies have been adequately recorded and documented in accordance with the approved Master Validation Plan(s) and Validation Protocols
  • Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed
  • Ensure that the validated state is maintained
  • As a Validation Engineer you will be responsible for all relevant Process / Equipment Validation activities
  • Review of the impact of change on the maintenance of the validated state, including execution of re-validation as required
  • Periodic review of documentation management system workflows to ensure both regulatory & business needs are satisfied
  • You will also be expected to contribute to other QA activities such as: NC/CAPA management, Supplier Management, Change Control

The ideal candidate:

  • You are an energetic person with a clear attitude towards progress and success
  • 3-5 years of validation experience in a medical device manufacturing environment
  • Bachelor's degree in Engineering, Manufacturing or related field preferred
  • You are very systematic and have a highly developed common sense
  • You are comfortable in independent decision making
  • Knowledge of medical device regulations and standards such as ISO 13485, GMP 21 CFR, MDR, ISO (production FMEA)
  • Knowledge of statistical techniques, Minitab user knowledge a distinct advantage
  • The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules
  • Proficient in English, German is a plus

The Process:

  • CV to: m.burgstaller@sciproglobal.de

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