QC 设备&LIMS高级工程师
BioNTech · Nantong
About the Role:
At BioNTech, we are driven by the mission to harness the power of science and technology to improve lives. As a QC LIMS & Equipment Senior Engineer, you will be responsible for implementing, managing, maintaining, and continuously improving our Laboratory Information Management System (LIMS), laboratory analytical instruments, and related digital platforms within the QC laboratory. Your work ensures compliance with GMP standards, data integrity requirements, and business needs—directly contributing to the success of our innovative therapies.
You will collaborate with cross-functional teams including IT, QA, QC, and international stakeholders to drive digital transformation in laboratory operations. This is an excellent opportunity to work at the forefront of technology and science in a global environment.
Your Contribution:
- Implementing and optimizing LIMS systems: Conduct requirement analysis, select vendors, manage system deployment/configuration, and coordinate with IT, QA, and QC teams for successful system launch
- Computerized system validation: Lead or support IQ/OQ/PQ activities; draft or review URS (User Requirement Specifications), FRS (Functional Requirement Specifications), risk assessments, test scripts, and validation reports to ensure compliance with GMP standards
- Workflow optimization: Design and improve electronic lab workflows for sample management, result entry/review/approval processes (including OOS investigations) to enhance operational efficiency
- Daily LIMS operations: Manage user access control, master data maintenance, audit trail reviews, troubleshooting issues, and workflow configurations
- System upgrades & change management: Oversee upgrades and changes by assessing impact and executing necessary testing/revalidation activities
- Technical support & training: Provide technical assistance to QC laboratory users; develop SOPs (Standard Operating Procedures), work instructions, and training materials
- Equipment management: Maintain equipment records/status tracking; coordinate qualification/requalification/calibration/preventive maintenance activities in compliance with GMP requirements
- Cross-functional collaboration: Work with IT teams on system integrations involving ERP/CDS/MES platforms; support OOS/OOT investigations as well as deviation/CAPA activities using system data analysis tools
A Good Match:
- Bachelor’s degree or higher in life sciences or engineering (e.g., Chemistry/Biology/Biotechnology/Pharmaceutical Engineering) or equivalent professional experience
- Proven expertise in LIMS systems implementation/administration; experience with computerized system validation (IQ/OQ/PQ) is highly desirable
- Strong understanding of GMP regulations (e.g., EU GMP Annex 11/21 CFR Part 11) with demonstrated ability to maintain compliance across digital platforms
- Familiarity with laboratory equipment lifecycle management including calibration/preventive maintenance activities
- Excellent problem-solving skills with a proactive approach to identifying risks related to data integrity/system functionality
- Proficiency in project management tools/software integration processes; prior involvement in global digitalization projects is an advantage
Join us at BioNTech to shape the future of healthcare through innovation. Together we can make a difference!
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