MES Lead 500
- Digitive LLC.
2 Hours Ago
NA
W2, C2C
Richmond-VA
10-23 Years
Required Skills: MES, Manufacturing Execution System, GxP, Validation Processes, PLC, Automation Systems Integration, Emerson Syncade, Electronic Batch Records, EBR
Job Description
Role Summary
The Recipe Developer Lead will be responsible for leading the recipe development workstream within the MES implementation, ensuring high-quality configuration, adherence to standards, and alignment with manufacturing and architectural requirements.
Key Responsibilities
- Lead and manage the recipe development team for MES implementation.
- Translate functional requirements and manufacturing processes into MES recipe design and configuration.
- Define and enforce recipe development standards, naming conventions, and best practices.
- Review and approve recipe configurations, workflows, and batch execution logic.
- Collaborate with the MES Architect to align development with overall solution architecture.
- Work closely with business and shopfloor stakeholders to clarify requirements and resolve design queries.
- Oversee development of recipe objects, equipment workflows, and electronic batch records (EBR).
- Ensure proper version control, migration, and configuration management across environments (Dev, Test, FAT).
- Support and guide the team during testing phases (internal testing, integration testing, FAT).
- Review and contribute to Functional Specifications (FS), Configuration Specifications (CS), and test documents.
- Ensure compliance with GxP and validation requirements in all development activities.
- Provide technical mentoring and guidance to developers.
Key Deliverables
- Approved Recipe Design and Configuration Framework
- Reviewed and validated recipe configurations and workflows
- Inputs/reviews for FS, CS, and test specifications
- Code/configuration review reports and quality checkpoints
- Configuration migration and version control records
- Support for FAT execution and issue resolution
Required Skills & Experience
- Strong experience in MES (preferably Emerson Syncade)
- Hands-on expertise in recipe authoring, workflow configuration, and EBR
- Good understanding of pharmaceutical manufacturing processes
- Experience in leading small to mid-sized development teams
- Knowledge of GxP, validation processes, and documentation standards
- Familiarity with integration with automation systems (e.g., DeltaV, PLCs)
