Merck KGaA
From Merck KGaA's careers page
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Your role： We are seeking a China-based technical expert to lead on-site HPLC chromatography column production at our Wuxi facility.
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
We are seeking a China-based technical expert to lead on-site HPLC chromatography column production at our Wuxi facility. The successful candidate will be responsible for production process design and validation, equipment qualification, quality control release, and cross-regional project coordination with global teams. This role requires a strong engineering foundation, deep hands-on knowledge of chromatography column manufacturing, and the ability to drive capability-building initiatives within a multinational environment.
Production Process Engineering & Optimization
Design, establish, and continuously optimize HPLC column manufacturing facility layout and manufacturing processes, including stationary phase slurry preparation, column packing, and end-fitting assembly.
Develop and maintain Standard Operating Procedures (SOPs), process flow diagrams, BOM creation, maintenance, and implementation, and batch manufacturing records.
Conduct process capability studies (Cpk/Ppk), statistical process control (SPC) analysis, and root cause analysis (RCA) for production deviations.
Drive scale-up and technology transfer of column packing processes from pilot to full production scale
Evaluate and qualify raw materials (silica substrates, bonded phases, organic solvents, hardware components) in collaboration with other HPLC production sites, procurement, supply chain, and quality.
Drive operational excellence to optimize key process parameters to improve yield and quality.
Demonstrated strong problem-solving skills in addressing quality defects and operational deviations effectively
Define and implement validation protocols for the end-to-end HPLC column manufacturing process
Equipment Qualification & Maintenance Management
Lead IQ/OQ/PQ validation for production equipment, including column packing machines, HPLC test systems, slurry preparation vessels, pressure/flow measurement instruments and other equipment required for manufacturing and testing.
Establish preventive maintenance (PM) schedules and coordinate with engineering to ensure equipment uptime and GMP compliance.
Manage calibration programs for critical measurement instruments in line with ISO/IEC 17025 or equivalent standards.
Quality Control, Release & Regulatory Compliance
Support QA audits (internal, customer, and regulatory); manage CAPA documentation; ensure compliance with GMP/GLP, ISO 9001, and relevant chemical industry standards (REACH, GHS/CLP).
Manage supplier qualification and incoming material inspection for key raw materials and hardware components.
Ensure complete, accurate, and audit-ready documentation is maintained across ERP, LIMS, QMS, and other relevant platforms.
Interface with regulatory affairs for product registrations and customer-specific qualification requirements.
Global Project Coordination & Cross-Functional Leadership
Serve as the Wuxi site production technical representative in global HPLC production projects, aligning with counterparts in Europe, North America, and Wuxi sites.
Drive localization initiatives for component sourcing and process adaptation while maintaining global quality standards.
Coordinate with R&D, marketing, and supply chain teams for new product introduction (NPI) and engineering change management (ECM).
Provide technical training and knowledge transfer to production operators and technicians to build local competency.
Master's or PhD degree in Chemical Engineering, Analytical Chemistry, Materials Science, Pharmaceutical Engineering, or closely related discipline (MSc minimum required).
Equivalent combination of education and demonstrated production engineering experience will be considered.
Required Experience (3–6 Years)
Demonstrated hands-on experience in HPLC column manufacturing or a closely related analytical consumables manufacturing environment. Experience with high-volume production and successful process scale-up is strongly preferred
Experience with IQ/OQ/PQ protocols and GMP/GLP regulatory environments in chemical or life science manufacturing.
Proficiency in statistical analysis tools (Minitab, JMP, or equivalent) and ERP/LIMS/document management systems.
Strong written and spoken English for global project participation and technical documentation.
Prior employment at a global HPLC/chromatography manufacturer (e.g. Shimadzu, Thermo Fisher Scientific, Danaher/Cytiva/Phenomenex, YMC, or equivalent), demonstrated track record of end-to-end process setup (0->1), validation, and volume ramp-up (target: >50,000 HPLC columns produced cumulatively).
Experience in slurry preparation, end-fitting assembly, and column conditioning for RP, NP, or ion-exchange applications.
Knowledge of silica surface chemistry, bonded phase characterization, and particle size distribution measurement.
Familiarity with chemical hazard management (REACH, GHS/CLP) and safe handling of organic solvents in a manufacturing setting.
Cross-regional leadership experience or ability to work effectively with teams across time zones.
Training in Lean Six Sigma, Kanban, Kaizen or other process improvement methodologies
Willingness and ability to travel internationally as required and the valid US Visa is an advantage for potential global project travel
Professional fluency in Mandarin and English, both written and spoken, with the ability to communicate technical information effectively across global teams.
Petency Area & Key Indicators
Technical – Process Engineering：Column packing technology; slurry preparation & conditioning; process & equipment validation (IQ/OQ/PQ); SPC/SQC
Technical – Analytical / QC：HPLC system testing; column performance parameters (N, As, k); method development basics; LIMS operation
Technical – Chemical Knowledge：Silica chemistry; bonded phase characterization; solvent compatibility; chemical safety (GHS/REACH)
Quality & Compliance：GMP/GLP; CAPA; audit readiness; supplier qualification; documentation integrity; ISO 9001
Project & Change Management：NPI coordination; ECM; global project alignment; milestone tracking; risk management
Communication & Collaboration：English fluency; cross-cultural teamwork; technical presentations; stakeholder management
Leadership & Capability Building：Operator training; SOP development; knowledge transfer; technical mentoring
Competitive compensation package, including a performance-based bonus
The opportunity to establish and lead a new HPLC column manufacturing capability in China
Direct collaboration with global R&D, manufacturing, quality, and supply-chain teams
Exposure to international technology-transfer and manufacturing-excellence programs
Access to technical training and professional development opportunities
A collaborative, inclusive working environment with opportunities for career growth
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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