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VALIDATION ENGINEER

 

Company:

ICDS RECRUITMENT
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Job Reference Number

14566173

Client ID:

RI/EM12504
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Posted On:

Feb 6 2012

Location:

OFFALY
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Job Type:

Contract

Salary:

NEGOTIABLE
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Benefits:
  • CAR PARKING
VALIDATION ENGINEER with 3+yrs experience in a high volume manufacturing environment required for 6 month contract with a view to permanency in the midlands.

RESPONSIBILITIES:

  • Review, preparation & approval of SOPs, qualification protocols, deviations and change controls
  • Execution of validation protocols for equipment and processes.
  • Management & Co-ordination of validation activities with internal departments, external contractors & suppliers.
  • Preparation, review & approval of risk assessments for facilities, equipment and processes.
  • Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents. Provide related updates to department management according to the latest EU/U.S and ICH requirements.
  • Review validation documentation from contract vendors to ensure that company requirements are met
  • Initiate and implement change control activities in accordance with site procedures
  • Providing Validation expertise to all areas of the facility.
  • Conduct training in Validation methodologies and related procedures as required.
  • Present validation systems at internal and external audits and support quality assurance programmes.
  • Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
REQUIREMENTS:

  • A Bachelor’s Degree in Engineering, Science or a related discipline required.
  • Minimum of 3 years validation experience in a similar role within a high volume manufacturing, regulated environment.
  • Candidates from a Medical Device background will have a distinct advantage.
  • Lean/Six Sigma Training an advantage
  • Strong statistical skills and process capability are required.
  • Computer literate
  • Self directed and results driven team player with excellent communication skills.
  • National & International travel is approx 10% of role.
www.icds.ie