Responsibilities:
1. System Design and Configuration: Contribute to the design and be responsible for the configuration and implementation of MES/LES solutions. This includes building and modifying electronic batch records (EBRs), system workflows, and configuring equipment integration based on defined requirements.
2. Process Optimization: Collaborate with operations and quality teams to analyze manufacturing and laboratory workflows. You will use MES/LES capabilities to help implement process improvements, reduce production cycle times, and enhance data integrity at the shop-floor level.
3. System Management and Support: Provide frontline technical support for MES and LES platforms. You will act as a key technical resource to troubleshoot and resolve system issues, ensuring high availability for our manufacturing and lab teams.
4. Integration: Assist with the integration between MES/LES and other critical systems, such as our ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data.
5. Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) for MES/LES enhancements and new implementations. You will be responsible for generating validation documentation and ensuring systems are maintained in a validated state, compliant with GxP and data integrity requirements.
6. Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities.
7. User Training and Enablement: Develop training materials and conduct training sessions to ensure that manufacturing and lab personnel are proficient in using the MES/LES systems effectively in their day-to-day roles.
What You Need to Succeed (Minimum Qualifications):
8. Educational Background: A Bachelor's degree in Engineering (, Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
9. Required Experience: 3+ years hands-on experience with the configuration, and support of an MES or LES platform (, Werum PAS-X, Emerson Syncade, POMSnet).
10. Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry.
11. Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles.
12. Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and how they integrate with higher-level manufacturing systems.
13. Database and SQL Skills: Experience with SQL for data queries to support troubleshooting, data extraction, and report generation.
What Will Give You the Competitive Edge (Preferred Qualifications):
14. Problem-Solving: Strong analytical and troubleshooting skills, with the ability to systematically diagnose and resolve technical issues.
15. Process Analysis: A solid understanding of business process analysis and workflow design. Ability to read and interpret process maps and requirements documents.
16. Cross-Functional Collaboration: Good communication and interpersonal skills, with a proven ability to work effectively in a team environment with operators, scientists, and management.
17. Cloud Platform Proficiency: Familiarity with Public Cloud platforms, specifically Microsoft Azure or Google Cloud Platform (GCP), is a plus.
18. DevSecOps: Familiarity with the concepts of DevSecOps, including Continuous Integration/Continuous Delivery (CI/CD) and source control (Git), is desirable.
19. Communication Skills: Good verbal and written communication skills, with the ability to collaborate effectively within a technical team.
Additional Information:
20. Travel: 0-10%
21. Location: Hook, UK - Hybrid Work Environment