Sr Validation Engineer I (Biotech)

Location: Oceanside, California, United States; onsite role

Salary: $123,930–$160,380 per year, with potential discretionary annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing CAR T-cell and T-cell receptor engineered therapies for cancer treatment.

What you will do

• Plan, execute, and document commissioning, qualification, and validation activities for manufacturing and Quality Control equipment, facilities, utilities, storage areas, processes, and automation systems.
• Develop validation master plans, schedules, protocols, technical reports, and lifecycle documentation for clinical and commercial manufacturing systems.
• Develop, execute, and analyze temperature mapping and autoclave heat penetration studies.
• Serve as the KNEAT subject matter expert and power user, supporting digital validation records, workflows, process improvements, and user guidance.
• Investigate validation deviations and failures, identify root causes, support corrective actions, and maintain compliant records and data integrity.
• Coordinate cross-functional validation projects, contractors, vendors, and internal teams, including support for regulatory inspections and submissions.

Requirements

• Bachelor’s degree in engineering, engineering technology, or a related field with 7+ years of equipment, facility, and utilities validation experience, or a master’s degree with 5+ years of biotech or pharmaceutical validation experience.
• Experience working in GMP/cGMP-regulated environments.
• Extensive hands-on experience with protocol authoring, field execution, data analysis, deviation resolution, and technical report generation.
• Knowledge of validation principles, practices, standards, and current Good Manufacturing Practices.
• Strong analytical, problem-solving, critical-thinking, communication, investigation, and report-writing skills.
• Availability for occasional night, weekend, or off-shift work based on business needs.

Nice to have

• Experience validating equipment, facilities, and utility systems in biotechnology or pharmaceutical manufacturing.
• Knowledge of cell therapy manufacturing equipment, utility systems, and supporting infrastructure.
• Experience with KNEAT, electronic validation workflows, and validation data management.
• Experience with temperature mapping, autoclave heat penetration studies, regulatory inspections, and health authority interactions.
• Proficiency in Microsoft Office applications.

Culture & Benefits

• Mission-driven work focused on developing cancer immunotherapies and curing cancer.
• Company-sponsored medical, dental, vision, and life insurance plans.
• Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
• Inclusive work environment that values diverse perspectives and individual differences.