Associate Scientist - PKMD - Lab Operations (Biotech)

Location: Thousand Oaks, California, United States

Salary: $91,528–$123,832 per year

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead and support computerized system validation for laboratory software and GxP-regulated applications.
• Develop risk-based validation strategies and maintain validation plans, requirements, qualification protocols, traceability matrices, and summary reports.
• Coordinate qualification and validation testing, system implementations, upgrades, changes, relocations, periodic reviews, and decommissioning.
• Review system security, user access, audit trails, electronic records, and data integrity controls.
• Investigate validation exceptions, deviations, and corrective actions while supporting audit readiness and regulatory inspections.
• Partner with laboratory operations, IT, automation, Quality, system owners, scientists, and external vendors; train users and maintain procedures and work instructions.

Requirements

• Master’s degree and 1 year of laboratory experience, or bachelor’s degree and 3 years of laboratory experience.
• Experience supporting equipment, quality, laboratory operations, information systems, or regulated environments is preferred.
• Experience with computerized system validation, lifecycle management, validation methodologies, risk-based validation, testing, documentation, and change control.
• Knowledge of GxP requirements, GLP or GCP environments, data integrity principles, and regulated system controls.
• Strong technical writing, organization, communication, and project coordination skills.
• Ability to work at the Thousand Oaks, California location.

Nice to have

• Advanced degree.
• 5+ years of experience in equipment, quality, laboratory operations, information systems, or regulated environments.
• Experience with laboratory instruments, data systems, or automation platforms.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable to the work location.