MES设计专员 - 1099/W2
MES Design Specialist - 1099/W2
MES设计专家为两个工作流提供灵活支持和独立评审能力。该职位不是初级支持岗位——需要具备真实的OpCenter实际操作能力，因为当主设计师满负荷时，该人员可能被分配一个中等复杂度的PI，并被期望独立推进。该专家还负责设计评审检查表的职责分离评审，这意味着他们必须具备足够的能力在没有指导的情况下识别设计错误、主数据缺失和测试用例覆盖问题。可以将此角色视为拥有更广泛职责的第三名设计师，而不是特定工作流的人员。
所需资格
- 2年以上实际操作西门子OpCenter执行制药配置经验——包括PI设计、测试PI构建、sMBR开发和MES主数据创建
- 在受FDA监管的制药生产环境中工作的经验，并具备对电子批记录GMP要求的明确理解
- 能够独立执行DRC评审（设计评审检查表）——针对其他工程师设计的PI进行评审，这需要能够批判性地评估设计决策，而不仅仅是检查格式
- 具备根据使用案例和sBMR模板构建测试PI的经验，用于子PI测试
- 熟悉MES主数据：工作中心、设备实例、类别、属性、状态和sMBR结构
- 熟练使用Kneat或同等电子验证管理系统进行验证表单管理和事件跟踪
- 熟练使用Veeva VQD或同等工具进行规范文件创建和文档管理
- 能够在时间压力下独立运作，并在不同工作流之间流畅切换，无需重新培训每个PI
优先考虑的资格
- 参与过有明确计划和里程碑承诺的正式MES实施项目（不仅仅是维护或支持工作）
- 熟悉传输请求流程和TEST/VAL/PROD环境管理
- 对SAP到MES或OSI-PI到MES接口有概念层面的了解
- 在多团队实施中具备灵活或跨工作流工作的经验
- 在制药MES环境中支持工程或端到端水运行的经验
关键工具与平台
西门子OpCenter执行制药（必需，实际操作） | Kneat（必需） | Veeva VQD（必需） | SAP（了解） | OSI-P
查看英文原文
The MES Design Specialist provides flex coverage and independent review capacity across both workstreams. This role is not a junior support role — it requires genuine OpCenter hands-on capability, because this person may be handed a mid-complexity PI and expected to move it forward independently when one of the Lead Designers is at capacity. The Specialist also serves as the segregation-of-duties reviewer for Design Review Checklists, which means they must be competent enough to identify design errors, gaps in master data, and test case coverage issues without guidance. Think of this as a third designer with a broader mandate rather than a specific workstream.
Required Qualifications
- 2+ years of hands-on Siemens OpCenter Execution Pharma configuration experience — including PI design, Test-PI build, sMBR development, and MES master data creation
- Experience working in an FDA-regulated pharmaceutical manufacturing environment with demonstrated understanding of GMP requirements for electronic batch records
- Ability to perform independent DRC review (Design Review Checklist execution) for PIs designed by another engineer — this requires the ability to critically evaluate design decisions, not just check formatting
- Experience building Test-PIs aligned to Use Cases and sBMR templates for Sub-PI testing
- Working knowledge of MES master data: workcenters, equipment instances, classes, properties, statuses, and sMBR structure
- Proficiency with Kneat or equivalent electronic validation management system for validation form management and incident tracking
- Proficiency with Veeva VQD or equivalent for specification file creation and document management
- Ability to operate independently under schedule pressure and shift between workstreams fluidly without needing to be re-onboarded to each PI
Preferred Qualifications
- Experience on a formal MES implementation program with a defined schedule and milestone commitments (not just maintenance or support work)
- Familiarity with transport request process and TEST/VAL/PROD environment management
- Exposure to SAP-to-MES or OSI-PI-to-MES interfaces at a conceptual level
- Prior experience functioning in a flex or cross-workstream capacity on a multi-team implementation
- Experience supporting engineering or E2E water runs in a pharmaceutical MES environment
Key Tools & Platforms
Siemens OpCenter Execution Pharma (required, hands-on) | Kneat (required) | Veeva VQD (required) | SAP (awareness) | OSI-PI / PI System (awareness) | Microsoft Teams / SharePoint
Originally posted on Himalayas