What are the responsibilities and job description for the Manufacturing execution System Specialist ( MES ) position at Stanley David and Associates?
Job Title: Manufacturing Execution System (MES) Specialist
Location: Boston, MA
Job Type: Full-time
Key Responsibilities:
Implement, configure, and maintain MES solutions to support pharmaceutical manufacturing operations.
Collaborate with cross-functional teams, including IT, engineering, quality assurance, and operations, to ensure seamless integration of MES with other systems like ERP and LIMS.
Develop and customize electronic batch records (EBRs) in line with GMP and FDA requirements.
Monitor and troubleshoot MES-related issues, ensuring minimal downtime and efficient resolution.
Provide MES training and support to end-users, ensuring effective utilization of the system.
Ensure compliance with industry standards, including 21 CFR Part 11 and other relevant regulations.
Lead and participate in MES-related validation and qualification activities.
Identify opportunities for process improvements and implement MES enhancements to optimize manufacturing workflows.
Stay updated with the latest trends and technologies in MES and pharmaceutical manufacturing.
Qualifications:
Bachelor’s degree in Computer Science, Engineering, or a related field; advanced degree preferred.
5 years of experience in MES implementation and support
Strong understanding of GMP, FDA regulations, and 21 CFR Part 11 compliance.
Proficiency in MES platforms such as Werum PAS-X, Emerson Syncade, Rockwell PharmaSuite, or similar systems.
Experience with ERP systems (e.g., SAP) and LIMS integration.
Excellent problem-solving skills and ability to work in a fast-paced environment.
Strong communication and collaboration skills.
Experience with data analytics and reporting tools is a plus.
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