Lead I - Engineering Design - AspenTech MES

UST; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

UST in Bengaluru seeks an MES Specialist with hands-on AspenTech MES experience to drive validation and qualification in a highly regulated biopharma/life sciences context.

You will prepare GxP/CSV/CSA documents, IQ/OQ/PQ protocols, ensure data integrity, and collaborate with cross-functional teams to support audits and remediation activities.

Qualifications

• Strong hands-on experience in MES, preferably AspenTech MES.
• Deep knowledge of GxP requirements in regulated life sciences.
• Experience preparing and maintaining GxP/CSV/CSA and qualification docs.
• Understanding MES validation lifecycle (IQ/OQ/PQ) and risk traceability.
• Familiarity with data integrity and audits.

Responsibilities

• Hands-on MES deployment and validation using AspenTech MES.
• Prepare and maintain GxP/CSV/CSA and qualification documentation.
• Oversee MES validation lifecycle and IQ/OQ/PQ protocols.
• Ensure data integrity and GxP compliance across processes.
• Collaborate with cross-functional teams and support GxP audits.

Skills

GxP compliance

Documentation

Audit readiness

Cross-functional collaboration

Independent work

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.

Role 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.

JD: Required Skills & Experience

• 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.

Skills

• AspenTech MES, GxP, Manufacturing Execution Systems