QA Validation Engineer

Posted 06 September 2023
SalaryCompetitive Rates
Job type Contract
DisciplineEngineering Leaders and Specialists, Life Sciences & Engineering Technologies
ContactPadraig O Luasa

Job description

A leading pharmaceutical organisation based in Sligo are looking for an experienced Validation Engineer to join their cleanroom expansion project.

The Position

  • Coordination/direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance/execution of Project Validation Plans and schedules.
  • Generation of validation protocols and final reports to cGMP standards.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various validation and qualification documents, management of validation, exception event, and change control processes.
  • Documenting all activities in line with cGMP requirements. Performing cross training within the Team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Coordinating activities to maximise the effectiveness of all team members.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

The Person

  • Qualification and/or degree in relevant engineering or scientific discipline.
  • 3 years plus validation/quality experience in sterile/aseptic environment specifically in the commissioning and qualification area.
  • 3 years plus knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
  • Strong communication (written and oral), presentation and troubleshooting skills required.
  • Effective interpersonal and organisational skills.
  • Ability to work well both independently and in a team environment.
  • Capable of prioritising work and multitasking.

To learn more, apply online or contact Pádraig on +353 87 428 0873 or please submit an updated CV.