Science & Pharmaceutical JobsValidation Engineer – Contractor | Pharma

  • SJ51205
  • Temporary/Contract
  • Mayo, Sligo

Collins McNicholas

Validation Engineer – Contractor | Pharma 

Opportunity for a validation contractor to support a Biologics start-up project. As Validation Engineer you will carry out the development and maintenance of the site validation program and ensure internal & external regulatory, quality, and compliance requirements are met.

The main areas of responsibility will include; 

  • Coordination/direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with company 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.

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

3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is desired

Further information available upon request. 

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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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