Senior Bioprocess MES Lead
Advanced Manufacturing Tech Solutions (AMTSOL)
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Job summary
Advanced Manufacturing Tech Solutions (AMTSOL) seeks a Process Lead to drive the MES workstream for a bioprocess manufacturing program in a GMP environment. You will map, analyze and translate upstream/downstream workflows into MES requirements and design recipes reflecting real shop-floor operations.
The role requires 10+ years in biopharma process manufacturing, hands-on MES implementation, and strong leadership with cross-functional collaboration. Based in St.
Qualifications
- Degree in chemical/biochemical engineering or life sciences.
- 10+ years in biopharmaceutical/bioprocess manufacturing.
- Hands-on MES implementation experience (PAS-X, Syncade, PharmaSuite, Opcenter).
- Strong GMP, batch record and data integrity knowledge.
- Leadership and stakeholder management skills.
Responsibilities
- Lead the MES project process workstream from mapping to go-live.
- Map and analyze upstream and downstream bioprocess workflows for MES requirements.
- Design MBR/EBR recipes with manufacturing, quality, MES teams.
- Drive process harmonization and standardization across operations.
- Support testing, validation and user acceptance to meet GMP needs.
- Support readiness, training and go-live adoption.
Skills
Education
Tools
Job description
Advanced Manufacturing Tech Solutions (AMTSOL) seeks a Process Lead to drive the MES workstream for a bioprocess manufacturing program in a GMP environment. You will map, analyze and translate upstream/downstream workflows into MES requirements and design recipes reflecting real shop-floor operations.
The role requires 10+ years in biopharma process manufacturing, hands-on MES implementation, and strong leadership with cross-functional collaboration. Based in St.
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