Job Description

The Validation Engineer II is responsible for planning, executing, and closing Installation and Operational Qualification (IOQ) activities for critical facility and utility systems within a pharmaceutical manufacturing environment, ensuring compliance with regulatory standards and internal quality requirements.

Responsibilities

• Develop and execute IOQ protocols for facility and utility systems
• Author detailed qualification protocols
• Perform qualification activities and document results
• Compile and finalize qualification reports
• Collaborate with engineering, operations, and quality teams
• Ensure adherence to FDA, EMA, and ICH guidelines
• Identify opportunities for improving qualification processes

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3–5 years of validation experience in pharmaceutical or biotech manufacturing
• Hands-on experience with system-level qualification
• Strong understanding of GMP, FDA, and ICH guidelines
• Proficiency in writing and executing IOQ protocols
• Ability to work in cleanroom environments
• Excellent documentation and communication skills
• Strong analytical and problem-solving abilities

Benefits

• No benefits