Validation Specialist

Position Title: Validation Specialist
Department: Operations
Reports To: Project and Equipment Validation Manager
Job Type: Full Time
Shift: Monday - Friday 08:00 AM - 05:00 PM
Exempt / Non-Exempt: Exempt


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