Validation Specialist II

Responsibilities

• Write, execute, and document validation protocols and test results in accordance with current standards.
• Manage equipment, facility, and system (EFS) qualifications to ensure the Validation Master Plan (VMP) is maintained on schedule.
• Act as a project owner, collaborating across teams to resolve complex issues and ensure timely project completion.
• Perform quality control tasks, including control charting, reviewing non-routine repairs, and assessing new equipment for qualification.
• Mentor and train staff on validated instrumentation, processes, and laboratory equipment.
• Provide quality oversight for new supply ordering and assess incoming chemicals and reagents.

Requirements

• A.A./A.S. degree with 4 years of applicable experience OR a B.S./B.A. degree with at least 2 years of applicable experience.
• Strong knowledge of GMP, GLP, and ISO regulatory requirements.
• Proficiency in Microsoft Office and general computer usage.
• Advanced mathematical skills and strong project management abilities.
• Excellent verbal and written communication skills with high attention to detail.
• Ability to work independently and manage multiple tasks in a professional laboratory environment.

Preferred Qualifications

• Degree in Microbiology or Biological Science.
• M.S. degree.
• ASQ certifications.
• Master Trainer certification.

About the Company

Nelson Labs, part of Sotera Health, is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Driven by the mission of Safeguarding Global Health®, we provide mission-critical sterilization and lab testing solutions to ensure the safety of patients and healthcare practitioners worldwide.