Validation Engineer

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Validation Engineer is responsible for managing, developing, and implementing Equipment and Facility Validation programs to ensure compliance with regulatory agency requirements, internal company standards, and current industry practices. This role supports GMP manufacturing operations and ensures that equipment, systems, and facilities remain in a validated state to meet quality and regulatory expectations.

Key Responsibilities

• Design, develop, and lead Equipment and Facility Validation initiatives.
• Ensure the Validation Master Plan remains current and aligned with regulatory and operational requirements.
• Prepare and execute IQ/OQ/PQ protocols for equipment, instruments, facilities, and utilities (HVAC, Building Automation Systems, compressed air, nitrogen systems, and environmental monitoring systems), as well as associated software, in compliance with cGMP standards.
• Conduct Computer System Validation (CSV) activities in accordance with FDA regulations and industry standards (e.g., GAMP 5).
• Collaborate cross-functionally with Manufacturing, Quality Assurance, and Engineering teams to support validation efforts.
• Ensure timely and successful completion of validation projects, including risk assessments and impact analyses for new systems or changes.
• Identify and resolve non-conformances or deviations encountered during IQ/OQ/PQ execution and implement appropriate mitigation strategies.
• Generate qualification reports and summarize validation results for review and approval.
• Perform requalification of equipment, facilities, and utilities in accordance with change control requirements.
• Initiate and manage quality records such as change controls, deviations, and CAPAs within the eQMS system.
• Promote a culture of continuous improvement across Manufacturing, Engineering, and Quality environments.
• Develop and maintain validation procedures in accordance with corporate guidelines, cGMP requirements, and ISPE standards.
• Review change controls, SOPs, calibration records, and maintenance documentation to ensure systems remain in a validated state.
• Provide oversight of GMP operations to ensure timely identification, documentation, and escalation of deviations, non-conformances, and compliance concerns, with appropriate risk mitigation actions.
• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in a technical or scientific discipline required; Master’s degree preferred.
• Minimum of 5 years of experience in a Validation or related role.
• Travel within (50 miles)
• Experience working in a cGMP-regulated environment strongly preferred.
• Experience in cell and gene therapy manufacturing preferred.
• Working knowledge of Code of Federal Regulations (CFR) requirements and validation-related cGMP standards.
• Experience leading validation projects or working with cross-functional teams.
• Experience authoring and reviewing technical documentation.
• Ability to perform physical job requirements, including standing, walking, and occasionally lifting up to 15 pounds.

Preferred Qualifications

• Experience with cell and gene therapy equipment.
• Certification in equipment calibration or maintenance.

Required Degree

• Bachelor’s degree in Engineering, Facilities Management, or a related field; Master’s degree in Pharmaceutical Sciences or a related discipline preferred.

Physical Requirements

• Ability to perform essential job functions in compliance with ADA, FMLA, and other applicable federal, state, and local regulations.
• Ability to maintain regular and punctual attendance.
• Must be willing to become gown-qualified and work in CNC/ISO8 environments.
• Ability to lift and carry up to 25 lbs.
• Ability to bend, stoop, reach, climb, and stand on elevated surfaces as needed.
• Ability to sit or stand for extended periods.
• Must be comfortable working with cell-based products, chemicals, or hazardous materials.