Senior Qualification And Validation Engineer

Dublin  ‐ Onsite
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Description

Pharmaceutical Company based in North Dublin is looking for a validation expert to support operations scale-up including equipment and facility commissioning and qualification.

Responsibilities/Tasks:
  • Write, review, approve and execute commissioning and qualification documents (equipment and facility)
  • Plan validation project schedules and prioritize validation activities in line with schedules and overall technology transfer priorities
  • Attend and sign-off on equipment FATs
  • Attend and sign-off on construction walk downs
  • Manage the vendor representatives in the field during commissioning/qualification
  • 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


Requirements:
  • Bachelor of Engineering or Science Degree in Engineering or related discipline
  • Minimum of 10 years' experience in the Pharmaceutical Industry in a validation role
  • Experience working in a solid oral dose environment
  • 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:
  • Process validation experience (including protocol write up and execution).
  • Process scale-up and optimization for manufacture of clinical and commercial products.
  • Experience in technical transfer of specified unit operations to contract manufacturers and supporting external process scale-up activities.
  • Computer systems validation experience


To hear more about this excellent opportunity please contact me Anna Mooney .
Start date
10/2015
From
Real Staffing
Published at
17.10.2015
Project ID:
1002303
Contract type
Permanent
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