Temporary Associate Validation Specialist

Temporary Associate Validation Specialist

We are seeking a Temporary Associate Validation Specialist to join our QA department on a full-time basis for up to one year starting summer 2025.

The role involves preparing complex validation procedures and protocols to ensure manufacturing compliance with regulatory requirements, internal standards, and industry practices. Responsibilities include analyzing validation data, preparing reports, troubleshooting issues, and maintaining validation documentation.

Key responsibilities include:

• Performing validation activities for facilities, equipment, and processes in accordance with EudraLex Volume 4 - GMP guidelines and other quality system requirements.
• Reviewing and updating validation procedures such as policies, master plans, and SOPs.
• Establishing and maintaining validation plans and schedules for requalification and temperature mapping.
• Collaborating with Engineering, Quality Assurance, and User Departments to ensure timely validation activities with minimal disruption.

The ideal candidate will have education and/or experience in areas including:

• Knowledge of EudraLex Volume 4, including Annex 11 and 15 validation requirements.
• Understanding of ISO 9001 and ISO 13485 quality systems.
• Familiarity with IQ, QQ, PQ, PV validation types.
• Experience with temperature mapping and calibration principles.
• Ability to author and execute validation reports and procedures.

If you are interested, please apply now for immediate consideration.

About Sekisui Diagnostics:

We focus on innovating highly accurate diagnostic tests, reagents, and systems to improve patient outcomes. With state-of-the-art manufacturing and a global sales network, we serve healthcare professionals worldwide. We offer competitive compensation, benefits, and a commitment to diversity and equal opportunity.