MES Recipe Author Associate

Job Summary

We are looking for an experienced MES professional to join our MES deployment team, responsible for recipe authoring, validation, and production support across manufacturing sites. The role requires strong hands-on expertise in MES platforms (PharmaSuite or Werum PAS-X) and a solid understanding of GMP-regulated manufacturing processes.

Responsibilities

• Author, configure, and maintain MES recipes - including Generic Master Batch Records (GMBR) and Production Master Batch Records (PMBR) - on PharmaSuite or Werum PAS-X platforms
• Support MES recipes in production, including troubleshooting, making changes, and ensuring recipe integrity during live operations
• Manage recipe migration and promotion across environments (Dev Test/QA Validation Production) following change control processes
• Perform end-to-end recipe validation, including test script authoring, execution, and documentation in line with GxP/CSV requirements
• Collaborate with cross-functional MES deployment engineers to plan and execute recipe releases and site go-lives
• Provide L2/L3 support for recipe-related incidents, performing root cause analysis and implementing corrective/preventive actions
• Ensure all recipe changes comply with data integrity (ALCOA+), 21 CFR Part 11, and Annex 11 requirements
• Partner with Manufacturing, Quality, and Validation teams to align recipe design with process and compliance needs
• Maintain accurate documentation for authored/modified recipes, including change records and test evidence

Required Skills and Experience

• 3-5 years of experience in MES recipe authoring and support
• Hands-on experience with PharmaSuite or Werum PAS-X MES platforms
• Practical exposure to GMBR and PMBR authoring and lifecycle management
• Experience moving/deploying recipes across multiple environments
• Working knowledge of recipe/system validation practices (IQ/OQ/PQ, test scripting)
• Experience in a production support role (L2/L3) within a regulated manufacturing environment
• Understanding of GxP, CSV/GAMP 5, and pharmaceutical manufacturing quality processes
• Strong troubleshooting and root-cause analysis skills
• Good communication skills to work with global/cross-site manufacturing and quality teams

Preferred Qualifications

• Prior experience working within a global pharmaceutical manufacturing IT/MES deployment team
• Exposure to change control and deviation management processes in a validated environment
• Bachelors degree in Engineering, Life Sciences, Computer Science, or related field

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.