Join Thermo Fisher Scientific s PSG IT CoE at Hyderabad and help redefine how digital manufacturing powers life-changing therapies. This position is responsible for designing, developing, validating, and maintaining electronic manufacturing recipes within the Manufacturing Execution System (MES). The primary responsibility of this role is to verify the accuracy of all recipes and workflows to match current production methods and meet cGMP, FDA 21 CFR Part 11, EU Annex 11, and company quality criteria. Collaborates with process engineers, manufacturing, and IT to convert batch process requirements into approved electronic records and automated workflows.

Key Responsibilities

Build and configure MES recipes using Rockwell PharmaSuite or comparable systems.
Interpret process specifications to develop scalable, validated electronic batch records.
Collaborate with process engineering, production, and quality teams to collect process details, standard operating procedures (SOPs), and master batch records (MBRs).
Convert paper-based or existing procedures into organized MES workflows to ensure accurate data and adherence to regulations
Partner with manufacturing, quality, and engineering teams to improve efficiency and compliance.
Maintain documentation and configuration logs aligned with GxP and FDA 21 CFR Part 11.
Lead recipe optimization initiatives that improve standardization and audit readiness.
Deliver 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 enhance recipe authoring efficiency, standardization, and reuse of recipe templates.
Support troubleshooting and resolution of recipe execution issues in production environments.
Collaborate with system administrators to handle version control, releases, and environment synchronization for MES.
Participate in global MES deployment or upgrade projects as a subject matter authority in recipe design.

Qualifications

Bachelor s degree in Engineering, Computer Science, Life Sciences, or related field.
Experience authoring MES recipes, preferably in Rockwell PharmaSuite.
Understanding of GMP, GxP, and data-integrity principles.
Strong analytical, communication, and cross-functional collaboration skills.

Strengths Youll Need

Diligent approach with a strong focus on processes.
Strong analytical and problem-solving skills.
Streamlined communication across different departments including Production, Quality Control, and Information Technology.
Ability to lead multiple recipe projects in parallel under agreed timelines.
Commitment to data integrity and right-first-time execution.

Preferred Certifications

Rockwell FTPS Recipe Authoring Certification (if applicable)
Six Sigma Green Belt or Lean Manufacturing Certification
GAMP5 Practitioner / CSV training credentials

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MES Recipe Author Professionals