QA Validation Engineer

Team Horizon is seeking a QA Validation Engineer to join our Clients Quality team and take the lead in ensuring the site validation program meets global regulatory and compliance standards.

 You’ll coordinate and execute validation activities for equipment, utilities, processes, and software—ensuring full compliance with FDA, EU cGMP, and GAMP standards. You’ll also support broader QA initiatives and drive continuous improvement across the site.

Why you should apply:

• Work on high-impact projects, grow your career, and be part of a global team dedicated to quality, safety, and innovation.

What you will be doing:

• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.

• Generation/maintenance/execution of the Site Validation Master Plan.
   
• Generation/maintenance/execution of Project Validation Plans and schedules.

• Generation of validation protocols and final reports to cGMP standards.

• Generation of validation investigations and implementation of corrective actions

• Creation/Review/Approval of various quality documents and test data.
   
• Management of validation, exception event, and change control processes.
  Maintenance and tracking of validation equipment, if applicable.

• Completing all required training before executing a task.

• Documenting all activities in line with cGMP requirements.

• Updating of validation procedures, job instructions and batch documentation to reflect current best practices.

• Performing cross training within the team and training of new team members.

• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
   
• Coordinating activities to maximize the effectiveness of all of the team members.
   
• Maintaining the overall cGMP compliance of the production areas.

• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

• Qualification and/or degree in engineering or scientific discipline.

   

• 3 years plus validation/Quality experience.

• 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry.

Candidate must be eligible to work in the EU