The MES Functional Analyst is responsible for designing, configuring, and deploying Manufacturing Execution Systems (MES) to support the digitalization and optimization of manufacturing operations. The specialist works closely with cross-functional teams, including production, quality assurance, IT, and project management, to gather requirements, design system configurations, and ensure seamless integration with other business systems. This role involves overseeing the MES lifecycle from requirements gathering through implementation, validation, user training, and ongoing system support.
Description of Work:
- Implementing and configuring the Werum PAS-X MES system to transition from paper-based or manual operations in production areas.
- Collaborating with various functional departments to prioritize and gather MES user requirements, followed by system design and deployment.
- Contributing to project milestones such as reviewing company documents (e.g., SOPs, batch records) to identify specifications needed for creating electronic records.
- Developing and configuring MES components, including recipes, workflows, equipment setups, master data, and electronic batch records, to fulfil the operational needs of Manufacturing and QA teams.
- Assisting with the development and testing of MES-related protocols. Ensuring MES documentation remains compliant with GAMP 5 standards throughout the system’s lifecycle.
- Managing system change controls, configuration documentation, and creating test plans to maintain MES validation.
- Coordinating with technical trainers to establish MES user training programs.
- Offering user support, troubleshooting on-site issues, and working closely with IT for problem resolution.
- Implementing initiatives to enhance process efficiency.
Job Knowledge:
- MES Systems Expertise: In-depth knowledge of Manufacturing Execution Systems (MES), particularly experience with Werum PAS-X or other widely-used MES platforms.
- Manufacturing Process Knowledge: Familiarity with manufacturing processes and systems, particularly in regulated industries such as pharmaceuticals, biotech, or food manufacturing.
- Regulatory Compliance: Understanding of Good Automated Manufacturing Practices (GAMP 5), FDA 21 CFR Part 11, EU Annex 11, and other industry standards for electronic records and computerized systems.
- Database and IT Knowledge: Experience with relational databases (e.g., Oracle, SQL) and basic IT infrastructure, as MES systems often interface with ERP, LIMS, or other business systems.
- Recipe and Workflow Design: Proficiency in designing MES workflows, recipes, equipment configurations, and electronic batch records tailored to business and quality assurance requirements.
- Systems Validation and Testing: Experience in system validation, including writing and executing test protocols (IQ/OQ/PQ), managing change controls, and maintaining a validated state for the MES.
- Documentation Skills: Ability to create and maintain technical and functional documentation, ensuring ongoing compliance and proper system use.
- Troubleshooting and Problem Solving: Strong problem-solving skills for diagnosing and resolving MES issues in real-time, working collaboratively with IT and operational teams.
- Project Management: Familiarity with project management methodologies for leading MES implementations, ensuring milestones and deliverables are met within timelines.
- User Training and Support: Experience in developing training materials and providing hands-on support to end-users during and after system deployment.
Qualifications:
- Self-motivated, excellent communication skills and enjoy working with people.
- Bachelor’s Degree: Typically, in a relevant field such as Computer Science, Engineering (e.g., Chemical, Mechanical, or Electrical), Information Technology, or Life Sciences.
- Manufacturing/Production Environment: Experience working in or supporting regulated manufacturing environments (e.g., pharmaceutical, biotechnology, or food industries).
- 3-5 years of hands-on experience in MES system implementation, configuration, and support (preferably Werum PAS-X or a similar MES platform).
