MES Recipe Author

Key Responsibilities

• Design, configure, and maintain electronic batch records (EBRs) and process recipes using Rockwe'll PharmaSuite MES or equivalent experience.
• Translate process requirements and master batch records into compliant MES recipes.
• Collaborate with process engineers, manufacturing, and quality teams to ensure recipes align with operational and regulatory needs.

• Ensure all recipe configurations and changes align with GxP, FDA 21 CFR Part 11, and data integrity standards.
• Maintain detailed documentation for recipe design, configuration, and change control.

• Recommend opportunities to optimize recipe design for efficiency, scalability, and compliance.
• Provide technical support and training to end users on MES recipe functionality.

• bachelors degree or equivalent experience in Engineering, Computer Science, Life Sciences, or related field.
• Proven experience with hands-on experience authoring MES recipes, with a proven focus on Rockwe'll PharmaSuite in pharmaceutical manufacturing environments. Equivalent experience is acceptable.
• Proven understanding of GxP regulations, electronic batch records, and data integrity requirements.
• Experience integrating MES with automation and enterprise systems.
• Strong analytical, problem-solving, and interpersonal skills.
• Experience working in a regulated, GMP-compliant environment is helpful.

• Expertise in Rockwe'll PharmaSuite MES recipe authoring
• Knowledge of pharmaceutical manufacturing processes and batch records
• GxP compliance and audit readiness
• Cross-functional collaboration with manufacturing, quality, and IT teams
• Attention to detail and documentation perfection