Job Summary

This role supports validation activities, including performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, and manufacturing support. Responsibilities also include preparing cGMP materials and documentation to meet regulatory standards for new and existing products, such as standard operating procedures (SOPs), technical reports, and risk assessments.

Key Responsibilities

• Generate and execute protocols for installation, operational, and performance qualifications.
• Analyze data and prepare comprehensive reports.
• Review and approve qualification documentation.
• Ensure all qualification activities comply with local procedures, industry standards, and regulatory requirements.
• Investigate protocol nonconformances and site deviations.
• Initiate and manage validation-related change controls and corrective/preventive actions.
• Author SOPs related to validation practices.
• Conduct and document formal risk assessments.
• Develop and implement validation programs.
• Work in cleanroom environments, including aseptic fill-finish operations.

Requirements

Education

• Bachelor’s degree in Engineering (required).

Experience

• 5–8 years of validation experience (preferred).

Skills

• Strong technical writing skills.
• Understanding of cGMP regulations.
• Proficient with Microsoft Office, Excel, and Visio.
• Excellent communication and collaboration skills across diverse teams.
• Effective time management for handling multiple activities with tight deadlines.
• Comfortable accessing equipment using ladders or navigating crawl spaces.

Work Environment and Physical Requirements

• Regularly sit for extended periods; occasionally stand, kneel, crouch, or crawl.
• Frequently lift up to 10 pounds; rarely lift up to 25 pounds.
• Frequent use of close vision with the ability to adjust focus.
• Regularly communicate via phone, email, and in-person conversations.

Special Requirements

• Flexibility to adapt to changing work schedules.
• Criminal background check required.
• Other duties as assigned.