Bioprocess MES Lead — Go‑Live & Standardization

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); St. Louis (MO); Sur place; USD 170 000 - 210 000; Plein temps

Résumé du poste

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) seeks a Process Lead to drive the MES implementation for bioprocess manufacturing in a GMP-regulated setting.

You will map processes, define MES requirements for upstream and downstream operations and collaborate with manufacturing, quality, and MES teams to ensure alignment with shop-floor realities. The role requires 10+ years in biopharmaceutical bioprocess, MES experience with PAS-X/Syncade/PharmaSuite/Opcenter, and the ability to lead

Qualifications

• Degree in chemical/biochemical engineering or life sciences or related discipline.
• 10+ years in biopharmaceutical/bioprocess manufacturing, process engineering or operations leadership.
• Hands-on MES implementation experience (PAS-X, Syncade, PharmaSuite, Opcenter).
• Strong understanding of upstream and downstream bioprocess operations.
• GMP, batch record practices and data integrity knowledge.
• Proven leadership, facilitation and stakeholder management skills.
• Based in, or willing to relocate to, St. Louis, MO, and authorized to work in the US.

Responsabilités

• Lead the process workstream of the MES project from mapping through go-live.
• Map and analyze bioprocess workflows and translate into MES requirements.
• Design MBR/EBR recipes reflecting shop-floor operations with other teams.
• Drive process harmonization and standardization across operations.
• Support testing, validation and user acceptance to meet GMP and operational needs.
• Support readiness, training and adoption at go-live.

Connaissances

Bioprocess manufacturing

Leadership

GMP knowledge

Data integrity

Stakeholder management

Formation

Chemical/biochemical engineering degree

Life sciences related discipline

Outils

PAS-X

Syncade

PharmaSuite

Opcenter

Description du poste

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) seeks a Process Lead to drive the MES implementation for bioprocess manufacturing in a GMP-regulated setting.

You will map processes, define MES requirements for upstream and downstream operations and collaborate with manufacturing, quality, and MES teams to ensure alignment with shop-floor realities. The role requires 10+ years in biopharmaceutical bioprocess, MES experience with PAS-X/Syncade/PharmaSuite/Opcenter, and the ability to lead