QC 设备&LIMS高级工程师 (Nantong, JS, CN, 226000)
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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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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1523 comparable Quality roles across 149 biopharma companies.
Salary context
248 of 1523 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
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Seniority mix
690 of 1523 peers have a known seniority level
Therapeutic area mix
1 of 1523 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
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