Hybrid Process Validation Lead — PPQ/CPV Expert

Altitude Technology Solutions Inc; Carlsbad (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Altitude Technology Solutions Inc in Carlsbad, CA is seeking a Process Engineering & Validation Expert to lead validation strategy, execution, and documentation across manufacturing, development, and quality teams.

You will design, schedule, and evaluate CPV/PPQ studies, manage validation activities, and contribute to audits within a cGMP environment while guiding cross-functional teams toward product quality and regulatory compliance.

Qualifications

• FDA or regulatory-agency BLA filing experience.
• Commercial manufacturing experience.
• Experience managing validation activities.
• Seven-plus years of experience in a cGMP environment.
• Bachelor's or Master's degree in biochemistry, chemistry, chemical engineering, microbiology, or related life science.
• Five-plus years of process validation, PPQ, and/or CPV experience.

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 subject matter expert during audits and customer meetings.

Skills

Process validation

CPV

BLA filings

Manufacturing

Regulatory audits

Technical leadership

Education

Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or related life science

Job description

Altitude Technology Solutions Inc in Carlsbad, CA is seeking a Process Engineering & Validation Expert to lead validation strategy, execution, and documentation across manufacturing, development, and quality teams.

You will design, schedule, and evaluate CPV/PPQ studies, manage validation activities, and contribute to audits within a cGMP environment while guiding cross-functional teams toward product quality and regulatory compliance.