Description

Key Responsibilities

• Execute and maintain validation activities for mixing tanks, manufacturing equipment, and production lines.
• Develop, review, and execute IQ/OQ/PQ protocols and validation documentation.
• Ensure compliance with FDA regulations, including 21 CFR Part 11 requirements.
• Support and maintain adherence to ISO 22716 standards and GMP practices.
• Partner with Quality, Engineering, and Operations teams to resolve validation gaps and drive continuous improvement.
• Provide validation support for an upcoming FDA remediation project.
• Perform hands-on troubleshooting and validation activities on the manufacturing floor (approximately 25-30% of the time).
• Assist with equipment qualification, process validation, and change control activities.
• Support calibration programs and documentation efforts (preferred experience).

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• Experience performing equipment, process, or production line validations in a regulated manufacturing environment.
• Working knowledge of FDA regulations, including 21 CFR Part 11.
• Experience with GMP environments and ISO 22716 standards preferred.
• Calibration experience is a plus.
• Strong documentation, problem-solving, and cross-functional communication skills

Key Skills

Education

Bachelor's degree