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Validation Engineer

Job Title: Validation Engineer
Location: Cork
REF: 89763
Job Published: about 1 year ago

Job Description

Contact: Bimi Felix
Telephone: 0868395533

Validation Engineer
Our client, a medical device company in Cork are currently looking to recruit a Validation Engineer for their site on a contract basis.

Overall Responsibilities:
The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of coating equipment, processes, and systems.

Position Duties & Responsibilities:
  • Responsible for Design for Manufacture, ensuring conformance with current equipment, process, and systems validation regulations
  • Responsible for determining the implications of validations upon; Product Quality, Patient Safety, and Data Integrity
  • Responsible for completing Equipment Lifecycle documentation, URS, FS etc
  • Participate in equipment, process, and software development and design review
  • Responsible for determining and implementing control measures to reduce the occurrence and possible impact of failures
  • Responsible for determining process inputs and factors for variation where process capability is required
  • Responsible for calculating process capability
  • Maintain, complete and accurate documentary evidence concerning Qualification and Validation exercises
  • Responsible for communicating and obtaining input/acceptance of stated exercises by relevant departmental personnel
  • Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s
  • Responsible for validation activities for NPI's / product transfers
  • Responsible for process and equipment risk management pFMEA / RA
  • Responsible for implementing/validating new technologies
  • Ensure HSE is included on all Quality change order procedure

Education & Experience Requirements:
  • Degree level qualification in Engineering/Science or Equivalent
  • Minimum 5 years post qualification experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry
  • Experience in aspects of QA, validation and ISO 13485.
  • Six Sigma Black Belt Certified
  • Statistical Engineering Qualification

For further information on the Validation Engineer role in Cork please contact Bimi Felix on 0868395533 /
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