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Hamlyn Williams

Syncade Recipe Author

Hamlyn Williams, , CA, United States

Job Description: Syncade Recipe Author

Position Overview:

We are seeking a detail-oriented and technically skilled Syncade Recipe Author to join our team. In this role, you will design, develop, and maintain electronic batch records (EBRs) and manufacturing recipes using the Syncade Manufacturing Execution System (MES). Your expertise will ensure accurate and efficient batch production, compliance with regulatory standards, and seamless integration with other operational systems.

Key Responsibilities:

  1. Recipe Development & Maintenance:
  • Develop, configure, and optimize Syncade recipes to meet manufacturing requirements.
  • Translate process specifications into electronic batch records (EBRs).
  • Collaborate with process engineers, manufacturing teams, and quality assurance to gather requirements and ensure recipes align with operational needs.
  1. System Configuration & Integration:
  • Configure Syncade workflows, operations, and tasks to enable efficient production processes.
  • Integrate Syncade MES with other enterprise systems, such as ERP (e.g., SAP) and automation systems (e.g., DeltaV).
  • Troubleshoot integration issues and provide system enhancements as needed.
  1. Testing & Validation:
  • Conduct thorough testing of recipes, including unit testing, integration testing, and user acceptance testing (UAT).
  • Author and review validation documentation, such as URS, FRS, IQ, OQ, and PQ.
  • Ensure compliance with regulatory standards, including FDA 21 CFR Part 11, GxP, and cGMP guidelines.
  1. User Support & Training:
  • Provide technical support to manufacturing teams during recipe execution.
  • Train end-users on Syncade recipe functionality and workflows.
  • Document standard operating procedures (SOPs) and best practices for MES usage.
  1. Continuous Improvement:
  • Identify opportunities to enhance system performance, reduce errors, and improve user experience.
  • Stay updated on Syncade software updates and emerging MES trends.
  • Collaborate with cross-functional teams to implement system upgrades and enhancements.

Qualifications:

  • Education: Bachelor’s degree in Engineering, Computer Science, Information Technology, or a related field.
  • Experience:
  • 3+ years of experience in Syncade recipe development or similar MES platforms.
  • Knowledge of manufacturing processes in industries such as pharmaceuticals, biotechnology, or food and beverage.
  • Technical Skills:
  • Proficiency in Syncade or other MES platforms (e.g., Werum PAS-X, Rockwell PharmaSuite).
  • Familiarity with automation systems like DeltaV or Allen-Bradley PLCs.
  • Understanding of SQL databases and programming/scripting languages (e.g., VBA, Python) is a plus.
  • Regulatory Knowledge:
  • Experience working in FDA-regulated environments.
  • Understanding of GxP, cGMP, and 21 CFR Part 11 compliance requirements.
  • Soft Skills:
  • Strong problem-solving abilities and attention to detail.
  • Excellent communication skills and ability to work collaboratively with diverse teams.
  • Strong organizational skills and ability to manage multiple priorities.