MES Engineer (Aspentech)

Job Title: MES Aspentech Engineer for Pharmaceutical Manufacturing

Key Responsibilities:

• Support the deployment, configuration, and optimization of AspenTech MES in pharmaceutical manufacturing settings.
• Collaborate with clients to translate operational needs and regulatory requirements into AspenTech MES solutions.
• Design, configure, and test Aspen MES components to align with GxP compliance and manufacturing workflows.
• Provide input on system architecture, batch execution models, and integration requirements.
• Troubleshoot Aspen MES application and integration issues; support root cause analysis and system improvements.
• Participate in the design and development of electronic batch records (EBRs) within Aspen MES.
• Support validation lifecycle activities (IQ, OQ, PQ) in compliance with FDA 21 CFR Part 11 and GMP.
• Deliver on-site and remote support during MES deployment, commissioning, and post-Go Live optimization.

Qualifications and Requirements:

• Bachelors Degree in Computer Science, Engineering, Information Systems, Life Sciences, or related disciplines.
• 5+ years of experience in MES implementations, preferably with AspenTech MES or similar platforms (e.g., Rockwell PharmaSuite, Werum PAS-X, Siemens Opcenter).
• Experience with Aspen MES configuration and integration
• Familiarity with pharmaceutical batch process automation and data integrity requirements.
• Knowledge of industry regulations and practices: GxP, 21 CFR Part 11, Annex 11.
• Strong analytical and problem-solving capabilities.
• Effective communication with both technical and non-technical stakeholders.
• Proactive, self-driven, and able to work in a fast-paced, client-facing environment.
• Team-oriented, with a commitment to quality and continuous improvement.