API Engineer

Key Responsibilities

• Design, develop, and support EBR and MES solutions for API manufacturing operations.
• Translate paper batch records and manufacturing instructions into structured, executable EBR workflows.
• Develop and maintain system integrations and APIs between EBR/MES, DeltaV DCS, PLCs, LIMS, and SAP ERP.
• Support batch execution, recipe management, version control, and change management within EBR systems.
• Collaborate with manufacturing, MSAT, QA, QC, engineering, and automation teams to ensure accurate representation of API processes.
• Troubleshoot EBR execution and system integration issues during manufacturing operations.
• Ensure compliance with GMP, ALCOA+, 21 CFR Part 11, Annex 11, and GAMP 5 requirements.
• Author and review CSV documentation including URS, FRS, IQ/OQ/PQ, risk assessments, and traceability matrices.
• Support system validation, audits, and regulatory inspections (FDA, EMA, M...