Job Description

Job Title: Utilities & Process Validation Engineer

Location: San Diego, CA

Position Summary

The Utilities & Process Validation Engineer is responsible for planning, executing, and documenting validation activities for facility systems, utilities (e.g. water, steam, HVAC, compressed gases, clean rooms), and process equipment in a regulated environment (medical device / diagnostics). This role ensures systems operate consistently and meet all applicable regulatory, quality, and safety standards (e.g. FDA, ISO 13485, GMP).

Key Responsibilities

• Develop validation strategy, plans, protocols, and reports (IQ, OQ, PQ, system performance qualification, requalification, periodic reviews) for facility, utilities, process equipment, and support systems.
• Define acceptance criteria, test methods, sampling plans, and controls for validation.
• Perform validation execution: install checks, functional testing, challenge testing, monitoring, data collection, calibration, troubleshooting deviations.
• Lead or support qualification of new or modified equipment or facility systems (e.g. HVAC, clean steam, WFI/RO, compressed air, HVAC zones, utilities, process piping).
• Conduct risk assessments, gap analyses, and process capability / statistical analysis as needed.
• Coordinate with cross-functional teams: engineering, project management, quality, manufacturing, maintenance, and facilities.
• Review design specifications, vendor documentation, and ensure that design meets validation needs.
• Oversee revalidation / periodic review of systems; monitor for drift or changes over time.
• Investigate validation failures / deviations, root-cause analysis, CAPA implementation.
• Maintain validation master plan, document control, and ensure traceability of validation documentation.
• Support audits / inspections and respond to regulatory / audit queries.
• Mentor or guide junior validation engineers / specialists.

Qualifications / Requirements

• Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or equivalent). Advanced degree a plus.
• 5+ years of experience in process / utilities / facility validation in a regulated industry (pharma, biotech, medical device, diagnostics).
• Deep knowledge of validation protocols (IQ / OQ / PQ), GMP, regulatory expectations (FDA, ISO 13485, etc.).
• Experience with utilities: HVAC, clean steam, WFI/RO, compressed air, gases, HVAC zones, etc.
• Statistical analysis skills (e.g. capability, control charts).
• Strong skills in documentation, writing protocols and reports, and attention to detail.
• Ability to lead validation projects, manage time, coordinate among stakeholders.
• Experience investigating and resolving deviations / CAPAs.
• Excellent communication skills, ability to present to quality / management / regulatory audiences.
• Relevant certifications (e.g. ASQ, or validations training) are a plus.

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