Role Description

JD: Required Skills & Experience

- Strong hands-on experience in MES, preferably AspenTech MES.
- Robust practical knowledge of GxP requirements and regulated life sciences/pharmaceutical environments.
- Proven experience in preparing and maintaining GxP/CSV/CSA and qualification documentation.
- Good understanding of MES validation and qualification lifecycle.
- Experience with IQ/OQ/PQ, URS, functional/design specifications, risk assessments, traceability, and validation protocols/reports.
- Solid understanding of data integrity principles and GxP compliance.
- Excellent documentation, communication, stakeholder management, and analytical skills.
- Ability to work independently and collaborate effectively with cross-functional teams. Preferred
- Experience working with pharmaceutical manufacturing or other highly regulated GxP environments.
- Experience supporting GxP audits/inspections and remediation activities.
- Familiarity with computerized system validation (CSV) / computer software assurance (CSA) practices.

Skills AspenTech MES, GxP, Manufacturing Execution Systems

📌 Lead I - Engineering Design - AspenTech MES (Bengaluru)
🏢 UST
📍 Bengaluru