Validation Engineer

MAIN DUTIES & RESPONSIBILITIES

* Design validation study features, such as sampling, testing, or analytical methodologies.
* Direct validation activities, such as protocol creation or testing.
* Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of problems.
* Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
* Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
* Review validation and compliance documentation, such as Process Flows, Training Records, or protocols.
* Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
* Prepare validation or performance qualification protocols for new or modified processes or equipment.
* Maintain validation test equipment by coordinating equipment Calibration requirements.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

* Third level degree in a science/engineering subject as a minimum.
* Previous validation experience is advantageous.
* Good understanding and application of GxP and regulatory requirements.
* Experience of wide range of validations including equipment and facilities validation plans.
* Excellent communication / interpersonal skills
* Attention to detail