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Validation Manager

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 21922

Validations Manager 

We have an exciting new role for a Validations Manager with a client in Sligo who have expanded their facility into a multi-million-dollar state of the art biologics plant, bringing groundbreaking scientific research to real life solutions.

The Validations Manager will carry out the development and maintenance of the ABB validation program and ensure regulatory, quality, and compliance requirements are met.

Key Responsibilities:

  • Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.

  • Generation, maintenance, and 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, and 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.

Education and Experience:

  • Bachelors/Masters degree in engineering or relevant scientific discipline

  • 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. 

  • 3 years plus of leadership experience.

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

  • 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. 

Competitive package available for this role as well as the opportunity to work with a employee-orientated company that offer great career developmental prospects both at home and abroad.


For a confidential discussion and more information on the role, please contact Davin Ferguson

071 9140251