Process Engineering & Validation Expert

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