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:
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
- Bachelor's in engineering or life sciences
- 0-2 years GMP experience (internships acceptable)
- Exposure to GMP, FDA regs (21 CFR 11, 210, 211), validation, or cleanroom environments
- Familiarity with risk tools like FMEA
- Technical writing, attention to detail, organization
- Cross-functional communication
- Problem-solving and willingness to learn
- 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)
Vacancy posted 3 days ago
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