Job Description
MES Project Management
Proven experience leading MES implementations from planning through go-live and hypercare.
Pharmaceutical / GMP Manufacturing Experience
Experience delivering projects in regulated pharma, biotech, medical device, or life sciences environments.
Validation & Compliance
Knowledge of GAMP 5, CSV (Computer System Validation), and 21 CFR Part 11 requirements
Electronic Batch Records (EBR) / MES Manufacturing Processes
Understanding of electronic batch records and MES-driven manufacturing operation
Strong Preferences:
Rockwell PharmaSuite MES
PMP or PRINCE2
Multi-site deployment experience
SAP/ERP integration exposure
Agile/Scrum experience