Lead I - Engineering Design - AspenTech MES

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.

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