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Full-time
bachelor degree
Posted 5h ago
~40 hrs/week
Responsibilities
Support the deployment, configuration, and optimization of AspenTech MES within pharmaceutical manufacturing environments. Design and test MES components and electronic batch records while ensuring GxP compliance and system integration.
Requirements
Requires a Bachelor's degree in Computer Science, Engineering, or a related field with over 5 years of experience in MES implementations. Must be familiar with pharmaceutical regulations such as 21 CFR Part 11 and GxP.
Full job description
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.
Related keywords
AspenTech MESPharmaceuticalsGxPGMPFDA 21 CFR Part 11Annex 11Electronic Batch RecordsEBRIQOQPQRockwell PharmaSuiteWerum PAS-XSiemens OpcenterBatch Process AutomationData Integrity
Delivering innovation through technology for Life Science manufacturing!
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2022
Headquarters
Singapore
LinkedIn followers
3,213
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization, helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation, Manufacturing Execution Systems (MES), OT Networking and Digital Technologies.
Offices: Singapore, SG · Cork, IE · Pune, IN · Dover, DE, US
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