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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)
Vacancy posted 5 days ago
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