About Your New Company
You will be joining a global biopharmaceutical company that focuses on developing and commercializing products contributing to oncology and eye care. The role is a 12-month contract in Sligo.
Job Description
As a QA Validation Engineer, you will coordinate the development and maintenance of the site validation program and ensure quality requirements are met.
Key Responsibilities
* Lead and participate in validating site equipment, utilities, processes, and software in line with AbbVie policies, FDA, EU cGMP, and GAMP standards.
* Develop and manage Site Validation Master Plans and Project Validation Plans, including timelines.
* Create validation protocols, reports, and investigations, ensuring cGMP compliance.
* Approve quality documents and manage validation, exceptions, and change control processes.
* Track validation equipment and complete required training prior to task execution.
* Update procedures and documentation to ensure best practices and provide cross-training within the team.
* Contribute to continuous improvement in manufacturing, quality, safety, and training systems.
* Communicate with management and peers to ensure cGMP compliance in production areas.
Requirements
* Bachelor's degree in an engineering or scientific discipline.
* At least 3 years of experience in cGMP, validation, and regulatory requirements relating to the biopharmaceutical industry.
* Ability to work as part of a team or on own initiative.
* Strong communication skills.
What We Offer
* A high-rate DOE (Days Off Every) experience in leading biopharmaceutical projects.
* Experience working in the biopharmaceutical industry.