Required Skills & Experience

Strong hands-on experience in MES, preferably AspenTech MES.

Robust practical knowledge of GxP requirements and regulated life sciences/pharmaceutical settings.

Proven experience in preparing and maintaining GxP/CSV/CSA and qualification documentation.

Positive understanding of MES validation and qualification lifecycle.

Experience with IQ/OQ/PQ, URS, functional/design specifications, risk assessments, traceability, and validation protocols/reports.

Strong 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

📌 Aspentech Mes Bengaluru
🏢 UST
📍 Bengaluru