Validation Engineer

  • Contract
  • Athlone

Website TPM05359

Summary:

Our client is a biopharmaceutical company based in Athlone, looking for a Validation Engineer to join its team. The successful candidate will be responsible for developing, executing and coordinating the CQV deliverables for the systems assigned to them. With responsibilities including performing facility, utility and equipment qualification.

Responsibilities:

  • Take the lead role in the verification of the Manufacturing Equipment and supporting Utilities.
  • Confirm that the Manufacturing Equipment and supporting Utilities are fit for its intended use.
  • Responsible for planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods, execution of verification tests and reviewing test results.
  • Performing all CQV activities in line with the SOPs.
  • With Support of SMEs the CQV Engineer will be responsible and have sufficient knowledge for determining how best to design and test systems to ensure they are suitable for intended purpose.
  • Accountable to format, write, deliver and review necessary commissioning/qualification/verification documentation in line with the standard approval process, and facilitate others to do so.
  • Lead and drive validation deviations where required.
  • Support change management process where required.
  • Support continuous improvement of Alexon’s facilities and equipment by risk assessing proposed changes to ensure the qualified state is maintained.
  • Generate and execute approved test scripts to demonstrate that proposed changes are appropriate and do not impact equipment or process validation.
  • Responsible for running the equipment to execute validation studies.
  • Generate EHS risk assessments to support field execution activities.
  • Serves as point of contact for validation studies performed by external contractors or vendors, coordinating the execution of studies.
  • Report work status to the Validation Manager.
  • Escalate issues as required.
  • Ensure compliance with site/project standards and relevant client procedures.

Qualifications & Experience:

  • Third level qualification in scientific or engineering discipline.
  • Direct experience performing validation studies in cGMP biopharmaceutical environment is required.
  • Experience with risk based verification approach and advantage.
  • Good understanding of Automation systems and associated control strategies.
  • The incumbent should possess knowledge of cGMP requirements for biopharmaceutical manufacturing.

To apply for this job email your details to Orla.daly@tandempm.ie.