Validation Engineer - Remote

Overview

We are seeking a Validation Engineer to join our team. The ideal candidate will leverage expertise in validation processes, quality systems, and regulatory compliance to ensure that all equipment, systems, and processes meet the required standards.

In Short

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
• Maintain and enhance validation quality systems to ensure compliance with regulatory requirements (e.g., FDA, EMA).
• Develop and improve standard operating procedures (SOPs), work instructions, and quality documentation related to validation processes.
• Lead and implement change management strategies to support product lifecycle changes.
• Plan, execute, and oversee validation projects from concept through implementation.
• Identify project risks and implement risk mitigation strategies.
• Drive continuous improvement initiatives to streamline validation processes.
• Provide technical expertise and troubleshooting support for validation-related issues.
• Collaborate with regulatory, quality, and manufacturing teams.
• Ensure that all validation specifications meet regulatory and process standards.

Requirements

• Bachelor’s degree in Engineering, regulatory affairs, or a related field.
• Minimum of 5-7 years of experience in validation engineering.
• Deep understanding of cGMP, FDA, EMA, and USP guidelines.
• Proficiency with quality systems including change control.
• Excellent communication skills and project management skills.
• Strong leadership and team management abilities.
• Detail-oriented with strong analytical and problem-solving capabilities.
• Ability to work in a fast-paced, dynamic environment.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings and ongoing recognition.
• Generous flexible paid time off program.
• Company-paid holidays and flexible working hours.
• Fully remote work options for most positions.