Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

工作地点
上海 (根据业务灵活安排)
一、岗位定位
该岗位将作为 Chromeleon（变色龙）软件在中国本地的核心技术定制工程师， 面向国内制药企业（以质检/QC 实验室为主）， 基于 Chromeleon SDK 与报表工具，为客户提供软件定制化开发与解决方案， 支持客户实现实验室流程自动化、报表合规化和质检效率提升， 从而增强赛默飞 HPLC 产品及软件在中国制药行业的整体竞争力。
二、主要职责

• 1. Chromeleon SDK 定制开发
• 基于 Chromeleon SDK / API，参与或主导客户定制开发项目，包括但不限于：
  o 基于 Sample / Sample Set 自动生成 Sequence（分析序列）
  o QC 场景下的数据处理流程自动化
  o 批量样品、方法、序列的自动化管理
  o 与客户现有系统（如 LIMS）的接口或数据交互设计
• 将客户业务流程转化为可执行的软件逻辑和技术实现方案
• 1. Chromeleon 报表（Report）定制开发
• 使用 Chromeleon Report Designer 与脚本功能，开发定制化 HPLC 报告：
  o 满足客户 SOP、药典（ChP / USP / EP）或内部质量规范
  o 实现 RRT、RRF、杂质含量、系统适用性、Pass/Fail 判定等逻辑
  o 支持 QC、方法开发（AD）及特殊分子（如 Peptide / Oligo）的报表需求
• 与客户及内部应用团队沟通，确保报表设计准确反映业务需求
• 1. 客户技术沟通与项目支持
• 直接与制药企业 QC、方法或 IT 相关人员沟通定制需求
• 输出清晰的技术方案说明和实施建议
• 与内部应用、服务、销售等团队协作，推动项目成功交付
• 1. 能力沉淀与效率提升
• 将成熟的定制方案沉淀为内部模板、示例或最佳实践
• 保持开放心态，主动使用 AI 等新技术工具（如 ChatGPT、Copilot）提升开发和交付效率
  三、任职要求
  必备条件
• 本科及以上学历，分析化学、计算机、自动化、制药工程或相关专业
• 3 年及以上 Chromeleon 或其他 CDS 软件（如 Empower、Open Lab）相关经验
• 熟悉 HPLC 工作流程及制药企业 QC 实验室实际业务
• 具备一定的软件或脚本开发能力，能理解 SDK / API 概念
• 熟悉 Windows 桌面应用开发环境，理解.NET运行机制、线程模型和进程间通信模型等
• 熟悉C#编程，能编写可维护、可测试代码
• 具备软件工程相关知识，了解软件开发流程
• 能阅读英文 SDK 文档和技术资料
• 能独立完成工作任务，同时具备良好的团队协作能力
• 有使用 AI 工具辅助开发、脚本编写或方案设计的实际经验
  优先条件
• 有 Chromeleon SDK 或二次开发经验
• 有制药企业 QC 实验室工作背景
• 有 LIMS、数据完整性或 21 CFR Part 11 相关经验

Position Title:

Chromeleon Software Customization Engineer (SDK & Reporting)
Location
Shanghai (flexible based on arrangement)

Role Summary:

This position serves as a local technical expert for Chromeleon software customization in China, supporting pharmaceutical customers (primarily QC laboratories) through SDK-based development and customized reporting.
The role focuses on enabling laboratory automation, regulatory-compliant reporting, and operational efficiency, thereby strengthening Thermo Fisher’s HPLC and software competitiveness in the Chinese pharmaceutical market.

Key Responsibilities:

Chromeleon SDK-Based Custom Development:

• Design and implement customer-specific solutions using the Chromeleon SDK / API, including:
  o Automated sequence generation based on samples or sample sets
  o Workflow automation for QC data processing
  o Batch and method management automation
  o Integration or data exchange with customer systems (e.g. LIMS)
• Translate laboratory business processes into executable technical solutions

Customized Chromeleon Report Development:

• Develop customized HPLC reports using Chromeleon Report Designer and scripting:
  o Compliant with customer SOPs and pharmacopeia requirements (ChP / USP / EP)
  o Including RRT, RRF, impurity calculations, system suitability, and Pass/Fail logic
  o Supporting QC, method development, and advanced molecule (Peptide / Oligo) workflows
• Work closely with customers and internal teams to ensure accurate implementation

Customer Communication and Project Support:

• Communicate directly with customer QC, method development, or IT stakeholders
• Prepare technical solution proposals and implementation documentation
• Collaborate with application, service, and sales teams to ensure successful delivery

Knowledge Building and Efficiency Improvement:

• Standardize reusable solutions, templates, and best practices
• Actively adopt AI tools (e.g. ChatGPT, Copilot) to improve development and delivery efficiency

Qualifications:

• Required
• Bachelor’s degree or above in Analytical Chemistry, Computer Science, Automation, Pharmaceutical Engineering, or related fields
• Minimum 3 years of experience with Chromeleon or other CDS platforms (e.g. Empower, Open Lab)
• Solid understanding of HPLC workflows and pharmaceutical QC laboratory operations
• Basic software or scripting capability and understanding of SDK / API concepts
• Ability to work independently with strong teamwork skills
• Practical experience using AI tools to support development or solution design
• Preferred
• Hands-on experience with Chromeleon SDK or secondary development
• Background in pharmaceutical QC laboratories
• Experience with LIMS, data integrity, or 21 CFR Part 11