Role Description

JD: Required Skills & Experience
Solid 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 settings.
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 (India)
🏢 UST
📍 India