Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
Position Summary
We are seeking a Process Engineer / Scientist III to support manufacturing operations for a cGMP / GRP production line in Suzhou. This role will be responsible for process support, technical troubleshooting, validation support, process transfer, documentation, and continuous improvement activities to ensure safe, compliant, and efficient manufacturing operations.
The successful candidate will work closely with Manufacturing, Quality, QC, Engineering, Supply Chain, and EHS to support day-to-day operations, process robustness, and future capability expansion.
Key Responsibilities
- Provide daily technical support to cGMP / GRP manufacturing operations, including process monitoring, troubleshooting, and issue resolution.
- Support process transfer, scale-up, startup, and operational readiness for new products, equipment, or manufacturing capabilities.
- Prepare, review, and update technical documents such as SOPs, work instructions, protocols, reports, risk assessments, and process-related records.
- Support validation-related activities, including process validation, equipment qualification support, cleaning validation support, and execution follow-up.
- Partner with Manufacturing and Quality teams to investigate deviations, support root cause analysis, and implement CAPA actions.
- Work with cross-functional teams to improve process performance, product quality, yield, and manufacturing efficiency.
- Support audit and inspection readiness by ensuring technical documentation and process controls are maintained in compliance with GMP and site requirements.
- Participate in change control, risk management, and continuous improvement activities for the manufacturing line.
- Analyze process data and generate technical summaries, trends, and recommendations for process optimization.
- Support training activities for manufacturing personnel on process-related topics, technical changes, and new procedures.
- Collaborate with Engineering on equipment/process interface issues and with QC/Quality on process-related quality matters.
Minimum Qualifications
- Bachelor’s degree or above in Life Sciences, Pharmaceutical Science, Biotechnology, Bioprocessing, Pharmacy, Chemical Engineering, or a related field.
- Minimum 5 years of relevant working experience in biopharmaceutical, life sciences, or regulated manufacturing environments.
- Hands-on experience in process support, manufacturing science, technical operations, process engineering, or related technical roles.
- GMP-related experience is required, including experience with GMP documentation, deviation/CAPA support, change control, validation support, and compliant manufacturing execution.
- Strong understanding of manufacturing processes, shop floor support, and technical problem solving in a regulated environment.
- Experience working cross-functionally with Manufacturing, Quality, QC, Engineering, Supply Chain, and EHS.
- Strong technical writing skills for protocols, reports, work instructions, and investigation summaries.
- Good English communication skills, both written and verbal.
Preferred Qualifications
- Experience in cell culture media, buffers, reagents, biologics, or related process manufacturing.
- Experience supporting tech transfer, scale-up, validation, or startup activities.
- Familiarity with SAP, MES, LIMS, electronic documentation systems, or manufacturing planning systems.
- Experience with Lean, continuous improvement, data analysis, or process optimization tools.
- Experience supporting customer audits, regulatory inspections, or internal compliance audits.
Key Skills and Competencies
- Strong technical and scientific problem-solving skills
- GMP compliance mindset
- Process troubleshooting capability
- Technical documentation and report writing
- Cross-functional collaboration
- Data analysis and process improvement
- Strong communication and execution discipline
- Ability to work effectively in a dynamic manufacturing environment
