Job Title: MES Engineer
Location: Malvern, PA
Reports To: Engineering Manager / IT Manager
Position Overview:
We are seeking an experienced MES Engineer to implement and support Manufacturing Execution Systems (MES) in our pharmaceutical manufacturing operations. The role will focus on integrating MES with other systems, ensuring compliance with regulatory standards (GMP, 21 CFR Part 11), and optimizing system performance.
Key Responsibilities:
- Implement & Support MES: Design, configure, and support MES systems for pharmaceutical production, ensuring seamless integration with ERP, SCADA, and LIMS.
- Troubleshooting & Optimization: Resolve MES-related issues, optimize system performance, and improve data accuracy.
- Documentation & Compliance: Ensure all MES activities are documented per regulatory requirements and assist with validation and audits.
- Training & Support: Provide user training and support, ensuring adherence to MES best practices.
Qualifications:
- Bachelor's degree in Computer Science, Engineering, or related field.
- 3+ years of MES experience, preferably in the pharmaceutical industry.
- Familiarity with MES platforms (e.g., Werum PAS-X, Rockwell PharmaSuite) and regulatory standards (GMP, 21 CFR Part 11).
- Strong troubleshooting, communication, and documentation skills.