Validation Engineer Job Description
We are seeking a Validation Engineer to join our team at Sligo, Ireland.
About the Role:
* Coordinate validation program development and maintenance.
* Ensure regulatory requirements are met.
* Participate in site Validation Program and Quality Assurance activities.
* Generate/maintain/execute Site Validation Master Plan, Project Validation Plans, and schedules.
* Develop validation protocols and final reports to cGMP standards.
* Implement corrective actions for validation investigations.
* Review/approve quality documents and test data.
* Manage validation, exception event, and change control processes.
* Maintain and track equipment.
* Complete required training before task execution.
* Document activities in line with cGMP requirements.
* Update procedures to reflect current best practices.
* Perform cross-training within the team and train new team members.
* Participate in continuous improvement programs.
* Maintain overall compliance of production areas.
About You:
* Qualification and/or degree in engineering or scientific discipline.
* 3+ years of validation/QA experience in medical device plastics processing, moulding, or assembly operations.
* Knowledge of cGMP and regulatory requirements relating to the medical device industry.
* Strong communication, presentation, and troubleshooting skills.
* Effective interpersonal and organizational skills.
* Ability to work independently and in a team environment.
* Capable of prioritizing work and multitasking.