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QC Analytical Engineer (Physical-Chemical Section) (Location: Hangzhou) 1 position
Responsibilities:
- Perform physicochemical testing of laboratory stock solutions and finished preparations.
- Conduct testing of purified water systems, raw materials, excipients, and packaging materials.
- Identify, document, and investigate non-conformances during sampling and testing; participate in risk assessment; implement immediate containment actions and execute deviation/CAPA activities related to materials.
- Prepare, standardize, and manage analytical reagents, including standard solutions and titration solutions, ensuring periodic re-standardization and compliance with laboratory requirements.
- Support laboratory management activities within the Quality Control (QC) department, including oversight of physicochemical testing materials and consumables.
- Draft and revise SOPs for physicochemical testing and related analytical instruments, ensuring execution in compliance with approved procedures.
- Participate in routine testing of potable water and manage outsourced testing activities, including documentation and tracking of submission records.
- Manage retention samples of products and materials, including storage, periodic inspection, and documentation of observations.
- Complete other tasks assigned by management.
Requirements:
- Bachelor’s degree or above in Pharmacy, Pharmaceutical Sciences, Biopharmaceuticals, or related disciplines.
- At least 3 years of QC testing experience in the pharmaceutical industry, with a minimum of 1 year in physicochemical analysis.
- Strong learning ability with the capability to analyze and troubleshoot laboratory issues.
- Hands-on experience in analytical method validation is required.
- Familiar with pharmacopeias (ChP, USP, EP) and regulatory requirements from NMPA and FDA.
Equipment Maintenance Technician (Location: Hangzhou) 1 position
Responsibilities:
- Develop and maintain site engineering management systems, including SOPs, operation procedures, and validation protocols.
- Lead qualification and validation activities for facility systems, including cleanrooms, purified water system, water for injection (WFI) system, pure steam system, Building Management System (BMS), Environmental Monitoring System (EMS), cold storage, and warehouse facilities.
- Conduct routine inspection and monitoring of utility systems, including water systems, compressed air systems, BMS/EMS, process utilities, and wastewater treatment systems; manage chemical preparation and ensure accurate completion of operational records.
- Oversee preventive maintenance, corrective maintenance, emergency repair, and calibration activities for plant equipment and utilities across the site.
- Manage deviations and change controls related to utility systems and engineering operations.
- Support GMP regulatory inspections and external audits, ensuring full compliance with engineering systems and documentation.
Requirements:
- Bachelor’s degree or above in Mechatronics, Mechanical Engineering, Industrial Engineering, or related disciplines.
- At least 5 years of relevant experience, including a minimum of 3 years in pharmaceutical engineering or equipment management.
- Solid understanding of equipment and facility systems in sterile pharmaceutical manufacturing environments, with hands-on maintenance experience.
- Familiar with pharmaceutical equipment, lifecycle management, and GMP regulatory requirements, with proven experience in GMP inspections and audits.
- Strong organizational, coordination, communication, and team management skills.
QA Verification (Location: Hangzhou/Tonghua) 1 position
Responsibilities:
- Review and approve validation documentation, including validation protocols and reports for equipment, facilities, cleaning processes, manufacturing processes, and computerized systems (CSV).
- Manage validation document lifecycle, including issuance, retrieval, and archiving in compliance with GMP documentation requirements.
- Develop and maintain the validation master plan (VMP) and ensure scheduled validation activities are executed on time.
- Manage and maintain temperature mapping and qualification instruments and provide technical guidance to user departments for validation execution.
- Support the Validation Manager in establishing, implementing, and maintaining the company validation system, and deliver related training programs.
- Participate in regulatory inspections, including GMP, NMPA, FDA, and other compliance audits.
- Collaborate with cross-functional teams to support validation and quality system activities.
- Perform other tasks assigned by supervisors or related departments.
Requirements:
- Bachelor’s degree or above in Pharmacy or related life science disciplines.
- Minimum 3 years of experience in pharmaceutical QA or validation within a regulated GMP environment, with experience in drafting or reviewing validation documentation.
- Familiar with temperature mapping equipment and validation tools used in pharmaceutical manufacturing environments.
- Strong understanding of pharmaceutical and medical device regulations, with in-depth knowledge of validation guidelines such as NMPA, ISPE, EMA, and FDA requirements.
- Strong analytical thinking, communication, coordination, teamwork skills, and a strong quality mindset.
Production Technician (Fermentation/Purification/Formulation) (Location: Tonghua) 6 position
Responsibilities:
- Perform manufacturing operations and related activities in accordance with GMP requirements, approved procedures, and production schedules.
- Monitor production process data and respond to deviations or abnormal conditions in a timely manner.
- Assist in the preparation and revision of manufacturing procedures, batch records, and equipment-related documentation.
- Perform routine cleaning, maintenance, and upkeep of production equipment and manufacturing areas.
- Participate in qualification, validation, regulatory inspections, and GMP audit activities as required.
- Complete other tasks assigned by supervisors or management.
Requirements:
- Associate degree or above in Biopharmaceuticals, Pharmacy, Applied Chemistry, Mechanical Automation, or related disciplines.
- Knowledge of practical experience in biopharmaceutical manufacturing processes, including fermentation, centrifugation, and purification, is preferred.
- Proficient in Microsoft Office applications, including Word and Excel.
- Strong sense of responsibility, willingness to learn, and ability to work diligently in a manufacturing environment.
- Good teamwork and communication skills.
QC Analyst (Liquid Chromatography/Biochemistry/Microbiology) (Location: Tonghua) – 3 positions
Responsibilities:
- Perform routine quality control testing of raw materials, excipients, packaging materials, intermediates, and finished products in compliance with GMP requirements and approved specifications.
- Monitor analytical data during testing processes and investigate deviations or abnormal results in accordance with laboratory procedures.
- Draft and revise analytical methods, testing procedures, equipment-related documents, and other QC technical documentation.
- Perform routine maintenance and housekeeping of laboratory environment and equipment to ensure compliance with GMP and safety requirements.
- Support analytical method development and perform method validation/verification activities as required.
- Complete other tasks assigned by supervisors or management.
Requirements:
- College diploma or above in Pharmacy, Pharmaceutical Engineering, Biochemistry, Biotechnology, Molecular Biology, Medical Laboratory Science, or related disciplines.
- Experience in QC laboratory testing (microbiological testing, biochemical assays, or molecular biology techniques) is preferred. Hands-on experience with electrophoresis, ELISA, and PCR is a strong advantage for biochemistry-related roles.
- Proficient in Microsoft Office applications (Word, Excel) for documentation, data organization, and basic data analysis.
- Strong sense of responsibility, attention to detail, and a proactive learning attitude, with the ability to analyze and tackle laboratory issues.
IT Engineer (Location: Tonghua) - 1 position
Responsibilities:
- Support the implementation of the IT department’s strategic plans, policies, and standards, ensuring compliance with company procedures.
- Provide on-site and remote support for software-related issues, including Windows OS, Microsoft Office 365, and other commonly used business applications.
- Maintain and troubleshoot IT hardware and infrastructure, including end-user computers, servers, data center equipment, printers, access control systems, and video surveillance systems.
- Manage IT assets and inventory, and support enterprise systems such as SAP Business ByDesign (SAP ByD).
- Act as a liaison between IT and business departments to ensure effective communication and alignment of IT and operational requirements.
- Participate in system onboarding training for new employees, including computerized system introduction and user guidance.
- Support GMP-compliant operations, including system backup management, time synchronization, user account and access management, and related data integrity activities.
- Perform other duties assigned by management.
Requirements:
- Junior college diploma or above in Information Technology, Computer Science, or related disciplines.
- At least 3 years of experience in IT end-user support; experience in pharmaceutical manufacturing environments is preferred.
- Familiar with office equipment such as multifunction printers, label printers, barcode scanners, etc.
- Strong learning ability to quickly adapt to new systems and applications.
- High sense of responsibility and strong teamwork spirit.
Verification and DI Compliance Manager (Location: Hangzhou) - 1 position
Responsibilities
I.Validation System Establishment & Maintenance
- Establish, implement, maintain, and continuously improve the company’s validation system (including CSV), covering the Validation Master Plan (VMP), validation governance processes, and related SOPs.
- Organize annual validation planning and coordinate cross-functional resources to ensure timely and compliant execution of validation activities for facilities, utilities, production equipment, computerized systems, processes, cleaning, and transportation systems.
- Review and approve key validation lifecycle documents, including URS, risk assessments, and DQ/IQ/OQ/PQ protocols and reports, as well as validation summary reports.
- Ensure continuous maintenance of validated state, including periodic re-validation and change-induced validation activities.
- Monitor GMP regulatory updates and guidelines (NMPA, FDA, EU GMP, ICH, ISPE, etc.) and update validation strategies and standards accordingly.
II.Data Integrity (DI) Management
- Serve as the company’s key person responsible for Data Integrity (DI), establishing and maintaining the DI management system, including policies, procedures, and monitoring KPIs, ensuring compliance with ALCOA+ principles across the data lifecycle.
- Identify, assess, and manage DI risks; lead gap assessments, internal DI audits, and corrective/improvement initiatives across functions.
- Oversee DI compliance in computerized systems validation (CSV) and system operations, including user access control, audit trail review, backup & recovery, and electronic signatures.
- Organize DI training programs and culture-building initiatives to enhance enterprise-wide data reliability awareness; investigate DI-related deviations and handle customer/regulatory feedback.
- Act as the primary DI subject matter expert during internal audits, supplier audits, customer audits, and regulatory inspections.
Requirements
- Bachelor’s degree or above in Pharmacy, Chemistry, Bioengineering, Pharmaceutical Engineering, Automation, or related disciplines.
- Over 8 years of validation experience in pharmaceutical, biologics, or medical device industries, including at least 3 years in validation or quality management leadership roles.
- Proven experience in establishing or upgrading validation systems; experience in sterile products or biology manufacturing is preferred.
- Strong knowledge of GMP and validation guidelines, including China GMP, EU GMP Annex 11/15, FDA 21 CFR Part 11/210/211, ICH Q7/Q9/Q10, ISPE GAMP5, etc.
- Deep grasp of Data Integrity regulations and expectations (e.g., MHRA, WHO, PIC/S DI guidance), with demonstrated ability to implement DI requirements into operational systems.