Validation Engineer

Finance Solutions

Validation Engineer (Entry-Level) - Summary

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)

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Vacancy posted 2 days ago

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