Quick Overview
Seniority
Mid Senior
Work mode
On Site
Location
Carlsbad, CA, United States
Posted
19 hours ago
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
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