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Lead Validation Engineer

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Scientific
  • Date posted: 04/10/2018
  • Job reference: BBBH14483

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Lead Validation Engineer

In this position you will be tasked to develop and maintain validation plan in line with global and regulatory requirements for validation of processes, equipment, equipment software, test methods and utilities in relation to my clients transfer project.

Key Responsibilities:

  • Plan and develop the transfer site validation project schedule with cross-functional teams and drive the achievement of this schedule through continuous monitoring of schedule progress, effective risk and issue management and prioritisation of validation activities in line with the IRIS transfer project schedules and plant priorities.
  • Lead, integrate & manage Iris transfer validation tasks and develop strategies on the Iris transfer validation project with multifunctional project teams ensuring the transfer project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards.
  • Understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures, work instructions and guidelines.
  • Prepare, review and execute Iris transfer project validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/work instructions and standards
  • Participate in the preparation of user requirement specifications for the Iris transfer project to ensure that they comply with Validation and GMP requirements as required
  • Execute/co-ordinate re-validation/qualification activities as required
  • Review/Approve change controls and assess impact of changes that affect Iris products.
  • Provide technical expertise during investigations, gap analysis, risk assessment and change control process.
  • Administer validation files and ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.

Key Requirements:

  • Bachelor's degree in field with 5+ years exp. OR
  • Master's degree in field with 3+ years exp. OR
  • Desirable to have previous experience in site transfers and Process/Equipment validations.
  • Ability to travel approximately 25% per month may be required

For more information on this and other potential opportunities please contact Kathryn on 016455250 or email

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