(CSV)工程师 - DeltaV
(CSV) Engineer - DeltaV
开发工程限定地区（需当地身份）
公司Advanced Manufacturing Tech Solutions (AMTSOL)
薪资未公开
工作地点Singapore
地域资格限定地区（需当地身份）
时区要求日间重叠约 9 小时，基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
注意地域限制：该职位明确限定在 Singapore 招聘。如果你是位于中国大陆的求职者，通常需要当地工作身份才能投递，或需与雇主确认是否接受独立合同（Contractor）形式合作。
AMTSOL 正在支持新加坡的一家制药制造项目，现正寻找一名 DeltaV CSV 工程师，负责根据 GxP、GAMP 5、21 CFR Part 11、EU Annex 11 和现场质量要求，规划、执行并记录 Emerson DeltaV 系统的验证活动。
主要职责
- 规划和执行 DeltaV 验证生命周期，包括验证策略、风险评估、需求和设计评审、可追溯性、安装确认（IQ）、操作确认（OQ）、性能确认（PQ）、回归测试和验证报告。
- 编写和审核验证交付物，如用户需求规范（URS）、功能规范（FS）、设计规范（DS）、风险评估、可追溯性矩阵、测试方案、偏差记录和验证总结报告。
- 验证 DeltaV 硬件和基础设施，包括 ProfessionalPLUS、应用和操作站、M 系列/S 系列/PK 控制器、CIOCs、I/O 系统、网络组件、服务器和虚拟化环境。
- 验证 DeltaV 软件配置和应用功能，包括控制模块、设备模块、单元模块、批次阶段、配方、报警、联锁、图形、接口和安全设置。
- 支持设计评审、工厂验收测试（FAT）、现场验收测试（SAT）、调试、确认、系统交接和批准变更的实施。
- 验证数据完整性和合规控制，包括审计追踪、用户账户管理、安全角色、电子签名、备份/恢复和时间同步。
- 支持已验证 DeltaV 环境的网络安全和系统加固工作。
- 支持与 MES、OSI PI/AVEVA PI 历史数据库及其他制造系统的接口验证，视情况而定。
- 通过关闭处理偏差、变更控制、测试偏差、供应商证据和验证文档。
- 与自动化、CQV、质量、IT/OT、制造和系统集成商团队密切协作。
任职要求
- 工程、自动化、仪表、计算机科学、制药技术或相关技术领域的学士学位。
- 在制药、生物技术或其他 GxP 监管环境中，至少 5 年的 DeltaV CSV 经验。
- 具备验证 DeltaV 硬件基础设施和 DeltaV 软件模块及批次应用的实际经验。
- 熟悉 GAMP 5、FDA 21 CFR Part 11、EU Annex 11、GMP 数据完整性要求和验证生命周期文档。
- 具备较强的技术写作能力、测试执行能力、偏差管理能力和利益相关者沟通能力。
查看英文原文
AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking a DeltaV CSV Engineer to plan, execute, and document validation activities for Emerson DeltaV systems in accordance with GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and site quality requirements.
Key Responsibilities
- Plan and execute the DeltaV validation lifecycle, including validation strategy, risk assessment, requirements and design review, traceability, IQ, OQ, PQ, regression testing, and validation reporting.
- Author and review validation deliverables such as URS, FS, DS, risk assessments, traceability matrices, test protocols, discrepancy records, and validation summary reports.
- Qualify DeltaV hardware and infrastructure, including ProfessionalPLUS, Application and Operator Stations, M-Series/S-Series/PK controllers, CIOCs, I/O systems, network components, servers, and virtualized environments.
- Validate DeltaV software configuration and application functionality, including Control Modules, Equipment Modules, Unit Modules, batch phases, recipes, alarms, interlocks, graphics, interfaces, and security settings.
- Support design reviews, FAT, SAT, commissioning, qualification, system handover, and approved change implementation.
- Verify data-integrity and compliance controls, including audit trails, user-account management, security roles, electronic signatures, backup/restore, and time synchronization.
- Support cybersecurity and system-hardening activities for validated DeltaV environments.
- Support validation of interfaces with MES, OSI PI/AVEVA PI historian, and other manufacturing systems, where applicable.
- Manage deviations, change controls, test discrepancies, vendor evidence, and validation documentation through closure.
- Coordinate closely with Automation, CQV, Quality, IT/OT, Manufacturing, and system-integrator teams.
Requirements
- Bachelor’s degree in Engineering, Automation, Instrumentation, Computer Science, Pharmaceutical Technology, or a related technical discipline.
- Minimum 5 years of DeltaV CSV experience in pharmaceutical, biotechnology, or another GxP-regulated environment.
- Proven experience qualifying DeltaV hardware infrastructure and validating DeltaV software modules and batch applications.
- Strong working knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP data-integrity requirements, and validation lifecycle documentation.
- Strong technical writing, test execution, discrepancy management, and stakeholder-coordination skills.
Preferred / Advantageous
- CSV experience with PLC/HMI or SCADA platforms such as Siemens SIMATIC, WinCC, or SIMATIC Logon.
- Experience using electronic validation platforms such as Kneat.
- Exposure to system integration, industrial cybersecurity, virtual infrastructure, or OT network qualification.
Originally posted on Himalayas
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