Validation Engineer

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Requirements:

• Bachelor’s degree in Engineering, regulatory affairs, or a related field.
• Minimum of 5-7 years of experience in validation engineering, with expertise in equipment, systems, and process validation.
• Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to validation processes.
• Demonstrated success in managing multiple projects in parallel.
• Excellent communication skills with the ability to work effectively across departments.
• Strong project management and leadership abilities.

Responsibilities:

• 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.
• Provide technical expertise and troubleshooting support for validation-related issues.
• Collaborate with cross-functional teams to align validation strategies with business objectives.