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Expert in Manufacturing Execution Systems
2 weeks ago
**Manufacturing Execution Systems Expert Wanted**
About this Role
We are seeking a skilled MES specialist to join our team.
This role involves designing, developing, and maintaining MES workflows and master data in POMSnet. Key responsibilities include collaborating with manufacturing, quality, and IT teams to implement new MES functionality and resolve issues.
Main Responsibilities:
- Design, develop, configure, and maintain MES workflows and master data in POMSnet.
- Collaborate with cross-functional teams to implement new MES features and troubleshoot system incidents.
- Support and lead MES-related projects, upgrades, and system validations.
- Evaluate and ensure MES compliance with cGMP, FDA regulations (21 CFR Part 11), and company standards.
- Create and maintain technical documentation, user guides, and training materials.
- Conduct testing, validation (IQ/OQ/PQ), and change control procedures for MES changes.
Qualifications and Requirements:
- Bachelor's degree in Chemical Engineering, Bioengineering, Computer Science, or a related field.
- 3-5 years of experience in MES solutions in Life Sciences.
- Experience in designing and configuring batch records within a Manufacturing Execution System (MES), preferably using MES platforms such as PAS-X, OpCenter, POMSnet.
- Strong understanding of pharmaceutical manufacturing processes, cGMP guidelines, and regulatory requirements, with knowledge of industry standards such as ISA-95.
- Experience in conducting testing, validation, and qualification activities for MES implementations, ensuring compliance with regulatory standards.
Key Skills and Qualifications:
- MES
- Technical Documentation
- DCS
- FDA
- ERP
- Manufacturing Processes
- Root Cause Analysis
- Compliance
- Audits
- Change Control
- Regulatory Requirements
- Manufacturing
- Chemical Engineering
- Technical Support
Tech Skills:
- PAS-X
- OpCenter
- POMSnet
- ISA-95