Senior Process Engineer (Biopharmaceutical)

Location: Shanghai, China; on-site

Company

Cytiva, part of hirify.global’s Biotechnology segment, develops equipment and solutions for biopharmaceutical research, vaccines, medicines, and cell and gene therapies.

What you will do

• Analyze customer user requirements for biopharmaceutical equipment, with a focus on downstream systems.
• Define process solutions through mass-balance analysis, equipment selection and sizing, and process and instrumentation diagrams.
• Prepare technical proposals, clarification and exclusion lists, project costings, schedules, and risk assessments.
• Lead project execution, including contract review, basic design, procurement coordination, supplier management, progress control, and financial monitoring.
• Coordinate qualification and verification activities, including pre-FAT, FAT, SAT, IV, and OV.
• Resolve complex technical issues, prepare final technical documentation, train team members, and drive continuous improvement.

Requirements

• BSc/MSc or equivalent in biochemical engineering, process engineering, chemical engineering, or a related discipline.
• At least 4 years of experience designing and engineering biopharmaceutical process equipment, including chromatography, ion exchange, PUPSIT, bulk filling, filtration, separation, purification, and single-use systems.
• In-depth knowledge of biopharmaceutical processes, technologies, products, downstream systems, and applicable industry guidelines such as ASME BPE, GAMP, cGMP, ISPE, and cFDA.
• Fluent English is required.
• Ability to work in multinational, interdisciplinary teams and travel when necessary.
• Experience collaborating with commercial, technical, marketing, product management, senior management, and external suppliers.

Nice to have

• Experience with PLC or electrical design.
• Experience with system hardware validation and qualification activities for biopharmaceutical process equipment.
• Experience coordinating mechanical, electrical, software, and automation subcontractors.

Culture & Benefits

• On-site work within the Custom Engineering, BioProcess China organization in Shanghai.
• Collaboration with associates and customers across a multinational organization.
• Commitment to health, safety, and environmental policies and procedures.
• Opportunities to teach colleagues, expand technical expertise, and participate in continuous improvement.