Aspentech MES

UST; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

UST Bengaluru is seeking a validation professional with hands-on MES experience in highly regulated pharma environments. You will apply GxP principles and contribute to IQ/OQ/PQ, URS, and design specifications while maintaining qualification documentation.

You will collaborate with cross-functional teams, ensure data integrity, and support audits and inspections. Strong documentation and stakeholder management skills are essential.

Qualifications

• Must have hands-on MES/GxP experience in regulated life sciences.
• Experience with CSV/CSA and qualification documentation.
• Familiar with IQ/OQ/PQ, URS, and design specifications.
• Understanding data integrity and GxP compliance.
• Excellent documentation and cross-functional collaboration.

Skills

MES experience

GxP compliance

Documentation

Stakeholder management

Analytical skills

Independent work

Cross-functional collaboration

Quality systems

Tools

AspenTech MES

Job description

• Strong 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.
• Good 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