Lead I - Engineering Design - AspenTech MES

We are looking for an experienced MES professional with strong expertise in GxP requirements and compliance documentation, particularly within regulated pharmaceutical or life sciences environments. The ideal candidate should have hands-on experience with AspenTech MES and a strong practical understanding of preparing, reviewing, executing, and maintaining GxP-relevant documentation, including qualification and validation documents.

Responsibilities

• Provide technical expertise in MES systems, with a focus on AspenTech MES.
• Develop, review, maintain, and manage GxP-compliant documentation throughout the system lifecycle.
• Prepare and maintain qualification and validation documentation, including URS, FS, DS, IQ, OQ, PQ, risk assessments, traceability matrices, and related validation deliverables.
• Ensure MES processes and documentation comply with applicable GxP, CSV/CSA, data integrity, and quality requirements.
• Collaborate with IT, Quality, Engineering, Manufacturing, and business stakeholders to ensure effective implementation and compliance of MES solutions.
• Support system qualification, validation, change control, deviation management, and periodic review activities.
• Ensure documentation is maintained in accordance with established SOPs, quality standards, and regulatory expectations.
• Support audits and inspections by providing relevant technical and qualification documentation.

Requirements

• 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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