M&S - IFB - USP Operation Expert (Insulin Manufacturing)

Location: Beijing, China; willingness to travel to Germany for knowledge transfer

Company

hirify.global is developing state-of-the-art, automated and environmentally friendly insulin production facilities in Beijing and Frankfurt through the InsuLINK program.

What you will do

• Represent upstream fermentation operational expertise within the project team.
• Support planning, design, P&ID reviews, HAZOP, functional design, URS authoring, and technical clarification with the Frankfurt facility.
• Define process-related and clean-utility user requirements and contribute to equipment and system designs.
• Develop SOPs and operational documentation and support equipment and system commissioning.
• Coordinate digital solution implementation, including MES and DCS.
• Support OQ, PQ, and PPQ execution, technology transfer, and scale-up activities with MSAT.

Requirements

• Bachelor’s degree in chemical engineering, biotechnology, bioengineering, or a related field, or technician/master craftsman qualification with extensive pharmaceutical production experience.
• More than 2 years of industrial experience in pharmaceutical manufacturing, with strong experience in insulin, biologics, or other pharmaceutical substances.
• Knowledge of cGMP requirements.
• Ability to work under pressure in a changing, matrix-driven project environment.
• Leadership, teamwork, communication, and cross-functional collaboration skills.
• English language skills required for speaking and writing.

Nice to have

• Technical background in insulin manufacturing.

Culture & Benefits

• Work within a cross-functional Operations and Engineering partnership.
• Participate in the development of a future-oriented and sustainable insulin supply infrastructure.
• Collaborate with colleagues in Beijing and Frankfurt.
• Travel to Germany for knowledge transfer.