Validation Engineer
- Location
- Carlsbad, California, United States
- Salary
- Not specified
- Company
- Akash pawar
Job description
Role & Company / Project Overview: Katalyst Pro is seeking an experienced Process Validation Engineer to lead validation strategy, execution, and documentation within a current Good Manufacturing Practice (cGMP) environment based in Carlsbad, CA. Key Responsibilities & Daily Duties: • Develop and implement process validation, equipment qualification, and Continued Process Verification (CPV) strategies. • Generate, review, and approve validation protocols, reports, and supporting technical documentation. • Plan, schedule, execute, and evaluate qualification and validation studies. • Lead validation investigations, impact assessments, and process control strategy development. • Manage process validation activities and cross-functional projects. Required Qualifications, Skills & Experience: • Minimum 7+ years of experience working in a cGMP-regulated environment. • Minimum 5+ years of experience in Process Validation, Process Performance Qualification (PPQ), and/or Continued Process Verification (CPV). • Experience supporting FDA or other regulatory agency Biologics License Application (BLA) filings. • Proven commercial manufacturing experience in a regulated pharmaceutical or biotechnology environment. • Education: Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or a related Life Sciences field. • Preferred: 10+ years of experience in manufacturing, process validation, PPQ, and CPV. • Preferred: Hands-on experience with cell culture, upstream processing, and/or downstream purification operations. • Preferred: Experience with cGMP document control systems, procedures, and validation documentation. • Preferred: Strong expertise in process and product data analysis and performance evaluation. • Preferred: Proven ability to lead and influence cross-functional teams without direct authority. Working Hours, Shifts & Location Details: • Location: Carlsbad, CA. Application Instructions: • Apply online or submit an updated resume via the provided application link or contact email.