Validation Specialist

Purpose:

The Validations Specialist will work directly under the supervision of the Project and Equipment Validation Manager, ensuring that equipment and processes meet quality and regulatory requirements.

Duties & Responsibilities:

• Tests and documents the validity and accuracy of processing systems and equipment
• Tests processes and manages process validations
• Provides technical support and implements operating procedures
• Create documentation to show that a manufacturing or production process has consistent results and meets quality standards
• Collaborate with Quality Assurance and coordinate validation activities and/or external laboratories and operations
• Create and write IQ/OQ/PQ protocols for validation, verification, and qualification of operations equipment
• Review and approve all validation protocols to industry standards for cGMP, ISO, AATB, and FDA requirements
• Perform temperature mapping of incubators, autoclaves, freezers, and refrigerators
• Stay current with industry trends, regulations, and best practices related to equipment validation, and provide recommendations for process improvements

Skills & Abilities:

• Knowledge of equipment validation principles and regulatory requirements, including FDA, GMP, and other relevant industry standards
• Excellent analytical, problem-solving, and critical thinking skills
• Strong attention to detail and ability to work independently with minimal supervision
• Proficient in using validation tools, software, and equipment
• Ability to meet deadlines and prioritize tasks effectively

Education & Experience:

• Bachelor’s degree required in a related field
• 0 -1 years of experience with regulatory requirements, including FDA, GMP and other relevant industry standards
• Professional certifications related to equipment validation (e.g., ASQ, Six Sigma) are desirable