Senior Validation Engineer

Senior Validation Engineer
Posted 2 months ago

The Role

Senior Validation Engineer based predominantly at the Tullamore facility. This role is a 1
year contract position.

Principle Duties

The successful candidate will be involved in

  • Plan validation project schedules and prioritize validation activities in line with schedules and overall technology transfer priorities
  • Write, review, approve and execute commissioning and qualification documents (equipment and facility)
  • Attend and sign-off on construction walk downs
  • Manage the vendor representatives in the field during commissioning/qualification (which may include travel to Europe as required)
  • Managing the preparation of equipment test runs
  • Execution of testing and the SAT/IOQ documents onsite
  • Complete review of vendor & construction docs to support commissioning and qualification activities
  • Ensure non-conformances and deviations are minimised and closed out in a timely manner
  • Attend project meetings with senior management and report progress
  • Supervision of contractors/vendors during commissioning
  • Preparation of commissioning and qualification summary reports
  • Manage commissioning and qualification of equipment and facility
  • Identify and implement system optimisations where required
  • Provide technical input during investigations, gap analysis, risk assessment and change control process
  • Provide validation related support to all departments
  • Ensure the equipment and facility meets the requirements for Phase 3 and commercial manufacture including the development of a project plan and gap analysis to meet this target

Minimium Requirements

  • Minimum of 5 years’ experience in the Pharmaceutical Industry in a validation role
  • Experience in preparation & sign off of SAT and qualification (IO/OQ) documentation
  • Experience in managing commissioning and qualification projects
  • Experience of both equipment and facility qualification
  • Excellent attention to detail and good documentation practices
  • Ability to understand project plans and schedules
  • Strong written and oral communication skills
  • Strong knowledge of GxP

Desirable Skills

  • Process validation experience (including protocol write up and execution).
  • Computer systems validation experience
  • Experience working in a solid oral dose environment

How to apply

Suitable Candidates should submit a CV and cover letter by close of business, December 9th, 2019 to

The salary is negotiable and dependant on the experience of the successful candidate

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