Process Engineering & Validation 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

Urgent Role

Title: US - Process Engineering & Validation Expert 5

Visa: OPT, CPT, -EAD, GC-EAD

Location: Carlsbad, CA 92010

Schedule: 8:00 a.m. 5:00 p.m.; hybrid, three days onsite and two remote

Period: 12 months

Should have strong experience with BLA filing PPQ, and/ CPV experience in upstream and downstream manufacturing

Please share interview availability of the candidate between 9 AM- 5 PM PST.

Role overview: Our client is seeking a Process Validation Engineer to lead validation strategy, execution, and documentation. The role provides technical leadership across manufacturing, development, quality, and project teams.

Key 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.

Basic 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.

Preferred qualifications:

• Ten-plus years of manufacturing, process validation, PPQ, and CPV experience.
• Hands-on experience with cell culture upstream or downstream purification operations.
• Ability to lead and influence teams without direct authority.
• Strong critical thinking and technical problem-solving skills.
• Familiarity with cGMP document control systems and procedures.
• Strong technical writing, communication, documentation, and organization skills.

Regards
Ravi sharma