Job Description & Requirements
We are are looking to hire a MES Systems Manager to join our MES team working at our client site, a pharmaceutical MNC. The selected candidate will be required to provide consultation and engineering service to the execution phase of the project. He/she will also be involved in the generation and ownership of IQ/OQ/PQ documentation and the Go Live Support.
Responsibilities
- Troubleshoot and provide solutions for MES & ERP problems in recipe execution and recipe authoring.
- Liaise with QA to provide approved change control documentation for all MES system changes.
- Design, create, write and execute to a high-quality standard, test and validation protocols, risk assessments, and system documentation.
- Design, create, write and/or make all required changes to MES & ERP Recipes, worksheets, equipment and material spec's including phase transition logic to a high-quality standard.
- Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
- Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
- Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-around and fixes identified.
- Work closely with IT regarding upgrades, patching, hardware support, security and system access and provide technical expertise in implementing upgrades and patching.
- Liaise with Global MES on required system improvements.
- Provide support to other MES system users as required to ensure business continuity.
- Participate in MES projects from initiation to ensure MES system or hardware requirements are taken into consideration.
- Ensure maintenance/replacement of MES hardware, printers, scales, scanners and bar-code labelers. Review for upgrades periodically.
- Keep other MES Team Members up to date on MES changes Documentation of all activities in line with cGMP requirements.
- Cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
- Adheres to and supports all health and safety standards, procedures and policies.
Job Requirements
- ASPEN product hands-on experience for full application configurations including interface with SAP and automation systems
- In-depth of knowledge of Pharmaceutical business process (Chemicals (W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
- Creation of business process flow diagram & recipe is a MUST.
- Knowledge on Industry Standards S88 and ISA S95
- Experience working on projects in the pharmaceutical and/or biotechnology industries knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector
- Excellent communication skills and collaborative with team members and external groups
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关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
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