Description

• The position will be responsible for developing, preparing, and executing IQ, PQ, OQ, protocols and repairs for equipment/system.
• Conducts risk assessments and develops qualification strategies for new and existing equipment/systems
• Analyzes and interprets qualification data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborates with cross-functional teams, including Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and Safety Health and Environment, to ensure seamless execution of qualification activities and successful achievement of qualification-related project milestones.
• Participates in process optimization and continuous improvement initiatives to enhance quality and efficiency.
• Ensures compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements
• Provides training and guidance to manufacturing and quality personnel on qualification processes and procedures.
• Maintains equipment/systems qualification documentation and ensures traceability and accessibility for audits and inspections
  
   

Qualifications:

 

• Bachelor’s Degree in Engineering of Life Science Required!
• 1+ year of experience in regulated manufacturing environment
• Strong technical writing, analytical, and problem-solving skills
• Demonstrated experience assisting with or supporting qualification activities within the medical device, pharmaceutical, or biotechnology industry

Key Skills

Education

Bachelor's degree