Remote Position
[Remote] MES Project Manager (Remote, with occasional travel to Vermont and Puerto Rico)
🌍 Remote · United States
💼 Full-time
Note: The job is a remote job and is open to candidates in USA. Steneral Consulting is seeking an MES Project Manager for a 12+ month contract. The role leads MES implementations from planning through go-live and hypercare, manages projects in regulated life sciences manufacturing, and oversees regulatory compliance and MES-driven operations.
Responsibilities
- Lead MES (Manufacturing Execution System) project implementations from planning to go-live and hypercare support
- Manage and deliver projects within regulated pharmaceutical, biotech, medical device, or life sciences environments (GMP manufacturing)
- Ensure project compliance with GAMP 5, Computer System Validation (CSV), and 21 CFR Part 11 regulatory requirements
- Oversee processes related to Electronic Batch Records (EBR) and MES-driven manufacturing operations
Skills
- Lead MES (Manufacturing Execution System) project implementations from planning to go-live and hypercare support
- Manage and deliver projects within regulated pharmaceutical, biotech, medical device, or life sciences environments (GMP manufacturing)
- Ensure project compliance with GAMP 5, Computer System Validation (CSV), and 21 CFR Part 11 regulatory requirements
- Oversee processes related to Electronic Batch Records (EBR) and MES-driven manufacturing operations
- Experience with Rockwell PharmaSuite MES
- PMP or PRINCE2 certification
- Experience in multi-site MES deployments
- Exposure to SAP/ERP integration
- Familiarity with Agile/Scrum methodologies
Benefits
- Remote work, with occasional travel to Vermont and Puerto Rico
Company Overview