We are seeking a skilled professional to fill the role of Validation Engineer, where they will be responsible for ensuring the quality and integrity of our products through validation and qualification processes.
Key Responsibilities
* Validate and qualify site equipment, utilities, processes, and software in compliance with regulatory requirements such as FDA, European cGMP, and GAMP standards.
* Develop and implement validation protocols and final reports to meet industry standards.
* Manage exception events and change control processes to maintain product quality.
* Maintain track of Engineering equipment and ensure it is up-to-date.
* Complete required training before executing tasks.
* Document all activities in line with regulatory requirements.
* Update Engineering procedures, job instructions, and forms to reflect best practices.
* Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
* C coordinate team activities to maximize effectiveness.
Requirements
* Minimum 3 years' experience in validation in medical device plastics processing, moulding, or assembly operations.
* 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.