Scientisit III, Operation
Thermo Fisher Scientific View all jobs
- Jiangsu
- Permanent
- Full-time
- 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.
- 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.
- 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.
- 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