Process Engineer (Cell Therapy Manufacturing)

Location: South San Francisco, California, United States; on-site

Company

hirify.global develops an advanced cell therapy manufacturing platform and related manufacturing technologies.

What you will do

• Develop, transfer, scale up, and continuously improve GMP cell therapy manufacturing processes across hirify.global sites.
• Own process knowledge, process mapping, capability monitoring, statistical analysis, continued process verification, and process validation activities.
• Lead technology transfer projects, manufacturability assessments, process adaptations, equipment user requirements, and manufacturing readiness activities.
• Develop and review SOPs, batch records, BOMs, training content, and manufacturing process reports.
• Investigate major deviations and quality events, lead root cause analyses, and implement CAPAs, change controls, and FMEA mitigations.
• Collaborate with software, manufacturing, process development, clients, and external partners on eBR, MES, QMS, ERP, and LIMS integrations.

Requirements

• Bachelor’s degree in a scientific or related field.
• At least 3 years of experience in biotech or biopharma cGMP operations, preferably in cell and gene therapy.
• Experience with pharmaceutical or biotech technology transfer and writing and reviewing GMP documentation.
• Knowledge of cGMP requirements, manufacturing safety procedures, regulatory inspections, product defects, and GMP deficiencies.
• Strong analytical, problem-solving, critical-thinking, planning, technical-writing, teamwork, and interpersonal skills.
• Ability to support multiple projects, influence cross-functional stakeholders, and provide technical leadership in GMP operations.

Nice to have

• Experience bringing biotechnology equipment and processes from design through GMP operational readiness.
• Experience with operational excellence or lean manufacturing.

Culture & Benefits

• Fast-paced, mission-driven environment focused on advancing cell therapy.
• Opportunity to work in a rapidly evolving organization with advanced manufacturing technology.
• Cross-functional collaboration with internal teams, clients, and external partners.
• Leveling is based on overall experience, education, and demonstrated knowledge during the interview process.