Role description
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
About UST
UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.
