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Vacancy Details

Engineering & Technical

Validation Engineer - Cork - 103182

Contract Type: Contract
Location: Cork
Date: 19/02/2019
Job Reference: 103182
Contact Name: Nick Harrison
Contact Email:

Job Description

Validation Engineer - Cork - 103182
Validation Engineer – NPI - Contract
Our client, a medical device company in Cork are currently looking to recruit a Validation Engineer for their site on a contract basis.

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

Organisational Interfaces:
Management, Engineering, R & D Personnel, IM Personnel, outside Suppliers, other sites

  • Responsible for 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 gauge R&R qualifications.
  • Participate in Worldwide equipment, process, and software development
  • 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 Quality Engineering responsibilities of NPI’s / product transfers
  • Responsible for process and equipment risk management pFMEA / RA
  • Responsible for implementing/validating new technologies.
  • Contribute towards company procedures regarding validations.
  • Responsible for conducting periodic review activities concerning the above.
  • Ensure HSE is included on all Quality change order procedure.
  • All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

Key Competencies Required:
  • Demonstrate standards of leadership – Managing complexity
  • Interdependent Partnership
  • Credo Values
  • Innovations
  • Customer / Market Place Focus
  • Excellent Communication Skills
  • Pro-active approach to work
  • Team Player
  • Flexible
  • Influencing skills
  • High level of validation knowledge
  • Highly computer literate
  • High level of GMP knowledge
  • Excellent project management skills
  • High attention to detail
  • High work standards
  • High level of numeracy
  • Excellent planning and organisation skills
  • Customer focused

Qualifications & Experience
  • Degree level qualification in Engineering/Electronics 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.

  • GD&T Certification
  • Six Sigma Black Belt Certified
  • Statistical Engineering Qualification

All applicants must have a working visa for Ireland for this contract role

For further information on this Validation Engineer role in Galway please contact Caroline Kingston on 086 8395531 /
Check out all our open jobs on our HERO Recruitment website –

Please Note: HERO Recruitment will not forward your details to any company without your prior approval

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