Validation Engineer

Role:
Supports validation activities across Manufacturing, QC (Analytical & Micro), and Facilities in a GMP-regulated biopharma environment. Focuses on developing, executing, and documenting validation for equipment, systems, and processes to ensure compliance with cGMP and regulatory standards.

Key Responsibilities:

• Assist with validation lifecycle activities: IQ/OQ/PQ, process, cleaning, and CSV
• Generate and execute validation protocols and reports (including vendor docs)
• Support equipment onboarding and verification
• Participate in risk assessments (e.g., FMEA)
• Coordinate with cross-functional teams (Manufacturing, QC, QA, Facilities)
• Assist with deviations, root cause analysis, and CAPA
• Maintain compliant documentation and support audit/inspection readiness

Qualifications:

• Bachelor's in engineering or life sciences
• 0-2 years GMP experience (internships acceptable)

Preferred:

• Exposure to GMP, FDA regs (21 CFR 11, 210, 211), validation, or cleanroom environments
• Familiarity with risk tools like FMEA

Key Skills:

• Technical writing, attention to detail, organization
• Cross-functional communication
• Problem-solving and willingness to learn

Work Environment:

• 100% onsite (Los Angeles)
• Mix of office and cleanroom (ISO 7/8) work
• Occasional off-hours/weekend support
• Requires PPE use and facility/equipment access (including rooftops/utilities)