{"id":3325335,"url":"https://alion.io/job/emd-group-process-engineer-hplc","title":"Process Engineer-HPLC","company":{"id":1844673,"name":"EMD Group","domain":"emdgroup.com","url":"https://alion.io/company/emdgroup","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"A","score":91,"open_postings":7,"ghost_share":0,"stale_share":0.571,"repost_share":0,"time_to_fill_p50_days":21,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Wuxi, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":21000,"max_usd":47000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5668},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"JMP","optional":false},{"name":"Kanban","optional":false},{"name":"LIMS","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-10-27T09:46:38Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-28T12:52:27Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Work Your Magic with us!\nReady 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.\nYour role：\nWe are seeking a China-based technical expert to lead on-site HPLC chromatography column productionat 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.\nProduction Process Engineering & Optimization\nDesign, establish, and continuously optimize HPLC column manufacturing facility layout and manufacturing processes, including stationary phase slurry preparation, column packing, and end-fitting assembly.\nDevelop and maintain Standard Operating Procedures (SOPs), process flow diagrams, BOM creation, maintenance, and implementation, and batch manufacturing records.\nConduct process capability studies (Cpk/Ppk), statistical process control (SPC) analysis, and root cause analysis (RCA) for production deviations.\nDrive scale-up and technology transfer of column packing processes from pilot to full production scale \nEvaluate and qualify raw materials (silica substrates, bonded phases, organic solvents, hardware components) in collaboration with other HPLC production sites, procurement, supply chain, and quality.\nDrive operational excellence to optimize key process parameters to improve yield and quality.\nDemonstrated strong problem-solving skills in addressing quality defects and operational deviations effectively\nDefine and implement validation protocols for the end-to-end HPLC column manufacturing process\nEquipment Qualification & Maintenance Management\nLead 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.\nEstablish preventive maintenance (PM) schedules and coordinate with engineering to ensure equipment uptime and GMP compliance.\nManage calibration programs for critical measurement instruments in line with ISO/IEC 17025 or equivalent standards.\nQuality Control, Release & Regulatory Compliance\nSupport QA audits (internal, customer, and regulatory); manage CAPA documentation; ensure compliance with GMP/GLP, ISO 9001, and relevant chemical industry standards (REACH, GHS/CLP).\nManage supplier qualification and incoming material inspection for key raw materials and hardware components.\nEnsure complete, accurate, and audit-ready documentation is maintained across ERP, LIMS, QMS, and other relevant platforms.\nInterface with regulatory affairs for product registrations and customer-specific qualification requirements.\nGlobal Project Coordination & Cross-Functional Leadership\nServe as the Wuxi site production technical representative in global HPLC production projects, aligning with counterparts in Europe, North America, and Wuxi sites.\nDrive localization initiatives for component sourcing and process adaptation while maintaining global quality standards.\nCoordinate with R&D, marketing, and supply chain teams for new product introduction (NPI) and engineering change management (ECM).\nProvide technical training and knowledge transfer to production operators and technicians to build local competency.\nWho you are：\nEducation\nMaster's or PhD degree in Chemical Engineering, Analytical Chemistry, Materials Science, Pharmaceutical Engineering, or closely related discipline (MSc minimum required).\nEquivalent combination of education and demonstrated production engineering experience will be considered.\nRequired Experience (3-6 Years)\nDemonstrated 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\nExperience with IQ/OQ/PQ protocols and GMP/GLP regulatory environments in chemical or life science manufacturing.\nProficiency in statistical analysis tools (Minitab, JMP, or equivalent) and ERP/LIMS/document management systems.\nStrong written and spoken English for global project participation and technical documentation.\nPreferred / Differentiating Qualifications\nPrior 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).\nExperience in slurry preparation, end-fitting assembly, and column conditioning for RP, NP, or ion-exchange applications.\nKnowledge of silica surface chemistry, bonded phase characterization, and particle size distribution measurement.\nFamiliarity with chemical hazard management (REACH, GHS/CLP) and safe handling of organic solvents in a manufacturing setting.\nCross-regional leadership experience or ability to work effectively with teams across time zones.\nTraining in Lean Six Sigma, Kanban, Kaizen or other process improvement methodologies\nWillingness and ability to travel internationally as required and the valid US Visa is an advantage for potential global project travel\nProfessional fluency in Mandarin and English, both written and spoken, with the ability to communicate technical information effectively across global teams.\nPetency Area & Key Indicators\nTechnical - Process Engineering：Column packing technology; slurry preparation & conditioning; process & equipment validation (IQ/OQ/PQ); SPC/SQC\nTechnical - Analytical / QC：HPLC system testing; column performance parameters (N, As, k); method development basics; LIMS operation\nTechnical - Chemical Knowledge：Silica chemistry; bonded phase characterization; solvent compatibility; chemical safety (GHS/REACH)\nQuality & Compliance：GMP/GLP; CAPA; audit readiness; supplier qualification; documentation integrity; ISO 9001\nProject & Change Management：NPI coordination; ECM; global project alignment; milestone tracking; risk management\nCommunication & Collaboration：English fluency; cross-cultural teamwork; technical presentations; stakeholder management\nLeadership & Capability Building：Operator training; SOP development; knowledge transfer; technical mentoring\nWhat We Offer\nCompetitive compensation package, including a performance-based bonus\nThe opportunity to establish and lead a new HPLC column manufacturing capability in China\nDirect collaboration with global R&D, manufacturing, quality, and supply-chain teams\nExposure to international technology-transfer and manufacturing-excellence programs\nAccess to technical training and professional development opportunities\nA collaborative, inclusive working environment with opportunities for career growth\nWhat 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!\nApply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!","description_format":"text","description_chars":7955,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Professional development"],"hiring_locations":[{"name":"China","iso":"CN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Advanced Materials","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-10-27T09:46:38Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":21,"reasons":["conf:4","velocity","win:early","comp:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/emd-group-process-engineer-hplc","json_url":"https://alion.io/job/emd-group-process-engineer-hplc.json","meta":{"generated_at":"2026-10-28T13:37:16Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":18424,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1844673},"rest":"https://alion.io/mcp/rest/get_company?id=1844673"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Femd-group-process-engineer-hplc"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Femd-group-process-engineer-hplc"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Femd-group-process-engineer-hplc"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/emd-group-process-engineer-hplc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Femd-group-process-engineer-hplc"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3325335}},{"tool":"search_jobs","arguments":{"company":"emdgroup.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3325335},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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