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Job Details

Validation Engineer

Company: Thornshaw Recruitment
Location:
Reference: KR9854
Closing Date: 16 Aug 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client, a Global healthcare company, are now recruiting for a Validation Engineer. This is a permanent position.

Requirements:

Responsible for the management & Co-ordination of Validation activities (software/ equipment/ process) with internal departments, external contractors & suppliers.

KEY RESPONSIBILITIES:

  • Review, preparation & approval of SOPs, qualification protocols, deviations and change controls.
  • Execution of validation protocols for 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.

ESSENTIAL CRITERIA:

  • A Degree in Engineering, Science or a related discipline required, and/or significant experience in a similar role and experience in a medical device environment
  • 2/3 years’ experience in validations required
  • Lean/Six Sigma Training an advantage
  • Experience with Software validation desirable
  • Strong statistical skills and process capability are required
  • Strong report writing skills
  • Self directed and results driven team player with excellent communication skills

 

For full details send your CV in confidence to tdunne@thornshaw.com or call +353 1 2784671

Log on to www.thornshaw.com for all current vacancies.   Thornshaw is a CPL group company.

Apply for this job: Validation Engineer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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