As a MES Recipe Author for Thermo Fisher Scientific located in Hyderabad, India, you will play a crucial role in designing, developing, validating, and maintaining electronic manufacturing recipes within the Manufacturing Execution System (MES). Your primary responsibility will be to ensure that all recipes and workflows are accurate, align with current production methods, and meet regulatory standards such as cGMP, FDA 21 CFR Part 11, EU Annex 11, and company quality criteria. You will collaborate with process engineers, manufacturing teams, and IT professionals to convert batch process requirements into approved electronic records and automated workflows. **Key Responsibilities:**
Build and configure MES recipes using Rockwell PharmaSuite or similar systems. - Interpret process specifications to create scalable, validated electronic batch records. - Collaborate with process engineering, production, and quality teams to gather process details, standard operating procedures (SOPs), and master batch records (MBRs). - Transform paper-based or existing procedures into organized MES workflows to ensure data accuracy and compliance with regulations. - Partner with manufacturing, quality, and engineering teams to enhance efficiency and compliance. - Maintain documentation and configuration logs in accordance with GxP and FDA 21 CFR Part 11. - Lead initiatives to optimize recipes, improve standardization, and enhance audit readiness. - Provide practical training and support to increase user adoption and system maturity. - Maintain lifecycle documentation including design specifications, configuration documentation, and change controls. - Drive continuous improvement initiatives to boost recipe authoring efficiency, standardization, and template reuse. - Support troubleshooting and resolution of recipe execution issues in production environments. - Collaborate with system administrators on version control, releases, and environment synchronization for MES. - Participate in global MES deployment or upgrade projects as a subject matter expert in recipe design. **Qualifications:**
Bachelors degree in Engineering, Computer Science, Life Sciences, or related field. - Experience in authoring MES recipes, preferably in Rockwell PharmaSuite. - Understanding of GMP, GxP, and data-integrity principles. - Strong analytical, communication, and cross-functional collaboration skills. **Strengths You'll Need:**
Diligent approach with a strong focus on processes. - Strong analytical and problem-solving skills. - Effective communication across different departments including Production, Quality Control, and Information Technology. - Ability to manage multiple recipe projects simultaneously within agreed timelines. - Commitment to data integrity and right-first-time execution.