Required Skills & Experience
Robust hands-on experience in

MES

, preferably

AspenTech MES

.
Strong practical knowledge of

GxP requirements and regulated life sciences/pharmaceutical environments

.
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 settings

.
Experience supporting

GxP audits/inspections and remediation activities.

Familiarity with computerized system validation (CSV) / computer software assurance (CSA)

practices

📌 Aspentech Mes Bengaluru
🏢 UST
📍 Bengaluru