Validation Engineer

Katalyst CRO; Carlsbad (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

Katalyst CRO seeks an experienced Process Validation Engineer to lead validation strategy, execution, and documentation within a cGMP environment. This role provides technical leadership across manufacturing, development, quality, and project teams.

The candidate will design and implement validation plans, generate and review validation documentation, and drive CPV/PPQ studies. Strong writing, analytical, and regulatory skills are essential for success in this senior role.

Qualifications

• 7+ years in a cGMP environment.
• 5+ years of Process Validation, PPQ, and/or CPV experience.
• FDA or regulatory-agency BLA filing experience.
• Commercial manufacturing experience.
• Experience managing validation activities.
• 10+ years of manufacturing, process validation, PPQ, and CPV experience.
• Hands-on experience with cell culture, upstream processing, and/or downstream purification operations.
• Experience with cGMP document control systems and procedures.
• Strong process and product data analysis experience.
• Experience leading and influencing cross-functional teams without direct authority.

Responsibilities

• Develop and implement process validation, qualification, and CPV strategies.
• Generate, review, and approve validation protocols and reports.
• Design, schedule, execute, and evaluate qualification and validation studies.
• Lead validation investigations, impact assessments, and process control strategy development.
• Analyze process and product data to evaluate performance and identify improvements.
• Serve as a validation SME during audits and customer meetings.
• Manage validation activities across cross-functional manufacturing, development, quality, and project teams.
• Provide technical leadership and influence teams without direct authority.

Skills

Process Validation

Technical Writing

Regulatory Compliance

Cross-functional Leadership

Quality Systems

Education

Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or related Life Science field

Job description

Summary

We are seeking an experienced Process Validation Engineer to lead validation strategy, execution, and documentation. The role provides technical leadership across manufacturing, development, quality, and project teams within a cGMP environment.

Roles & Responsibilities

• Develop and implement process validation, qualification, and CPV strategies.
• Generate, review, and approve validation protocols and reports.
• Design, schedule, execute, and evaluate qualification and validation studies.
• Lead validation investigations, impact assessments, and process control strategy development.
• Analyze process and product data to evaluate performance and identify improvements.
• Serve as a validation SME during audits and customer meetings.
• Manage validation activities across cross-functional manufacturing, development, quality, and project teams.
• Provide technical leadership and influence teams without direct authority.

Education & Experience

• 7+ years of experience in a cGMP environment.
• 5+ years of Process Validation, PPQ, and/or CPV experience.
• FDA or regulatory-agency BLA filing experience.
• Commercial manufacturing experience.
• Experience managing validation activities.
• Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or a related Life Science field.
• Strong technical writing, communication, documentation, and organizational skills.
• Strong critical thinking and technical problem-solving abilities.
• 10+ years of manufacturing, process validation, PPQ, and CPV experience.
• Hands-on experience with cell culture, upstream processing, and/or downstream purification operations.
• Experience with cGMP document control systems and procedures.
• Strong process and product data analysis experience.
• Experience leading and influencing cross-functional teams without direct authority.