Collins McNicholas

Senior Validation Engineer 

Experienced Engineer required on a exciting new project in the pharma sector in Sligo. As Senior validation Engineer you will be required to carry out the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met.

  • Coordination / direction and active participation in the validation and qualification of site 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 maximize the effectiveness of all of the team members.

  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Requirements for the role ; 

  • 3 years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area

  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.

  • Strong communication (written and oral), presentation and troubleshooting skills required

  • Effective interpersonal and organizational skills.

  • Ability to work well both independently and in a team environment.

  • Capable of prioritizing work and multitasking.

  • A minimum of 3 years’ experience in a cGMP regulated environment.

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

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