We are currently seeking a Senior Validation Specialist to join our team on a contract basis. This role will be responsible for ensuring site-wide validation and regulatory compliance.
About the Position
As a Senior Validation Specialist, you will coordinate and maintain the site validation program, ensuring compliance with FDA, European cGMP, and GAMP standards.
Key Responsibilities
* Develop, execute, and maintain Validation Master Plans and Project Validation Plans.
* Prepare and execute validation protocols, reports, and investigations to cGMP standards.
* Lead validation and quality assurance for site equipment, processes, and software.
* Support regulatory compliance through robust documentation, audits, and process improvements.
* Manage change control, exception events, and corrective actions.
* Provide cross-training, mentorship, and support to team members.
* Actively contribute to continuous improvement in manufacturing, quality, and safety systems.
Requirements
* Degree in an engineering or scientific discipline.
* 3+ years' experience in validation/quality within medical device plastics processing, molding, or assembly operations.
* Strong knowledge of cGMP and medical device regulatory requirements.
* Excellent communication, organizational, and troubleshooting skills.
* Ability to work independently and as part of a team, with strong prioritization and multitasking skills.