Validation Engineer

Katalyst-Healthcares-; Carlsbad (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

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

You will develop and implement validation strategies, generate and review protocols, schedule studies, and serve as validation SME during audits. Requires 7+ years in cGMP, 5+ years in PV/PPQ/CPV, and hands-on cell culture or downstream

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.
• Hands-on cell culture or upstream/downstream operations.
• Experience with cGMP document control systems and procedures.
• Strong technical writing, communication, and organizational skills.

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 teams.
• Provide technical leadership and influence teams without direct authority.

Skills

Process validation

Validation leadership

Data analysis

Technical writing

Problem solving

Cross-functional collaboration

Education

Bachelor's or Master's degree in Life Sciences

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.