Job Overview:
We are seeking a skilled Validation Specialist to join our team. As a key member of our operations, you will be responsible for ensuring the quality and compliance of our equipment, processes, and software.
The successful candidate will have a deep understanding of regulatory requirements and industry standards, including cGMP, FDA, and European regulations. They will also possess excellent documentation and review skills, with experience in developing and maintaining site validation master plans.
In this role, you will be involved in generating, executing, and tracking validation protocols, as well as creating final reports to cGMP standards. You will work closely with cross-functional teams to ensure overall cGMP compliance of production areas.
Main Responsibilities:
* Coordinate and participate in the validation and quality assurance of site equipment, utilities, processes, and software
* Generate, execute, and track validation protocols
* Create final reports to cGMP standards
* Maintain and update site validation master plans
* Manage exception event and change control processes
Requirements:
To be successful in this role, you will need:
* Over 2 years of validation experience in medical device plastics processing, molding, or assembly operations
* Detailed knowledge of cGMP and regulatory requirements relating to the medical device industry
* Strong documentation and review skills
* Experience developing and maintaining a site validation master plan within the Medical Devices or Life Sciences manufacturing sector
Person Specification:
We are looking for someone with:
* A Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology, or a related discipline
* At least 3 years of validation engineering experience
* Excellent collaboration, communication, and attention to detail
* A strong understanding of validation concepts and documentation
What We Offer:
This is an exciting opportunity to join our team and contribute to the success of our operations. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.