Process Development Engineer (Biotechnology)

Location: Singapore Manufacturing - Tuas

Company

hirify.global develops biotechnology medicines for patients with serious illnesses.

What you will do

• Coordinate complex technology transfer, process qualification, process monitoring, floor support, and unit-operation troubleshooting activities.
• Lead or support investigations and communicate findings to technical teams and leadership.
• Compile and analyze process data using Excel, JMP, and SIMCA to support decisions and predictive actions.
• Author technical protocols, assessments, and product impact assessments.
• Verify data in technical reports, spreadsheets, and regulatory filings.
• Prepare technical documentation and presentations using strong written and verbal communication.

Requirements

• Master’s degree, or a bachelor’s degree with 2 years of directly related experience, or an associate’s degree with 4 years of directly related experience, or a high school diploma/GED with 6 years of directly related experience.
• At least 4 years of relevant experience in commercial biotechnology or pharmaceutical manufacturing.
• At least 2 years of experience in regulated environments, including cGMP.
• In-depth knowledge of cell culture processes, including single-use and harvest technologies.
• Experience providing floor support, troubleshooting unit operations, and resolving and documenting cGMP investigations.
• Knowledge of regulatory and cGMP requirements, engineering principles, advanced statistical analysis, technical writing, and presentations.

Culture & Benefits

• Collaborative and inclusive work environment.
• Professional development opportunities.
• Competitive benefits and support for professional and personal growth.
• Medical requirements apply to the role; required medical check expenses are covered by the company.