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Validation Engineer

Job Title: Validation Engineer
Contract Type: Contract
Location: International
REF: 87765
Job Published: over 1 year ago

Job Description

Validation Engineer

Our client, a Medical Device company in Germany are currently looking to recruit a Validation Engineer for their site on a12 month contract.

Consulting role great rates available
Candidate must have Medical Device experience and be willing to commute/relocate to Germany.

Equipment Validation (mainly)
  • Extensive experience in installation and qualification of production related equipment
  • Automation experience would be beneficial, lots of automated steps on line
  • Experience with test method installation/qualification
  • Ideally experienced in medical device industry / regulated environment
  • Knowledge of ISO, FDA, EN and other regulatory requirements
  • Generation of URS and related documents
  • Quality system knowledge (Non-conformance/CAPA knowledge)
  • Ability to write technical protocols and reports under own initiative
  • Background in manufacturing/process development a help
  • Software knowledge would be a big help, but not a necessity
  • Also, any experience with MES would be useful going forward - possibly
  • Experience working on a remediation project - bonus
  • 5+ years' experience

Process Validation
  • Analyses process, product, material or equipment specifications and product performance requirements.
  • Extensive experience generating IQ, OQ and PQ protocols and reports under own initiative
  • Trained on Lean/Six Sigma methodologies (advantageous) - good understanding of Cpk/Ppk metrics
  • Implementation of in process controls - SPC
  • Knowledge of Design of Experiments (DOE) methodology
  • Design of processes/Process development background a big help
  • Experience with test method validation/gage R&Rs
  • Ability to troubleshoot and improve processes
  • Good documentation skills
  • Previous experience working with, FDA, ISO, EN, and other regulatory standards
  • Ability to generate PFMEAs, URS etc
  • Knowledge of quality systems (Non-conformance/CAPA system/Design controls/Design Transfer etc a bonus)
  • Team player, link between operations and R&D, worked as part of a cross functional team previously
  • Some leadership experience a benefit
  • ISO 13485 knowledge, FDA 820 CFR
  • 7+ years' experience

For further information on this Validation Engineer role in Germany please contact Deirdre Finnerty on 091730022 /
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