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.