Senior Engineer (Biopharmaceutical Manufacturing)

Location: Thousand Oaks, California, United States; up to 10% domestic travel and occasional after-hours coverage for 24/7 operations.

Annual salary: $115,494.60–$156,257.40 USD

Company

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

What you will do

• Provide engineering support for drug substance manufacturing facilities and lead equipment or facility-system improvements.
• Translate business and design requirements into equipment and system specifications, supporting construction, startup, commissioning, qualification, and validation.
• Coordinate equipment maintenance, establish performance metrics, monitor operating limits, and support reliability improvements.
• Troubleshoot production issues, lead root cause analysis, and implement corrective and preventive actions to reduce downtime.
• Support new product and technology introductions, equipment modifications, spare-parts identification, job-plan development, and engineering runs.
• Ensure equipment and systems meet safety, environmental, health, and regulatory requirements.

Requirements

• Doctorate degree; or a master's degree with 2 years of engineering experience; or a bachelor's degree with 4 years; or an associate's degree with 8 years; or a high school diploma/GED with 10 years of engineering experience.
• Bachelor's degree in biotechnology, industrial, chemical, or mechanical engineering preferred.
• 6+ years of relevant experience, including 5+ years in biopharmaceutical operations or manufacturing preferred.
• Experience with regulated environments such as cGMP, OSHA, or EPA and GMP quality systems including change control, non-conformances, CAPAs, qualification, and validation.
• Knowledge of biopharmaceutical production equipment and systems, including cell culture reactors, chromatography, filtration, filling, lyophilization, autoclaves, CIP systems, clean steam, and water for injection.
• Strong analytical, leadership, technical writing, communication, collaboration, and project-management skills; flexibility to support 24/7 operations.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Sponsorship for this role is not guaranteed.