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