Bioprocess MES Lead for GMP and Process Standardization

Advanced Manufacturing Tech Solutions; St. Louis (MO); On-site; USD 140,000 - 200,000; Full time

Job summary

Advanced Manufacturing Tech Solutions seeks a Process Lead to guide the MES project, ensuring bioprocess manufacturing is accurately captured, optimized, and embedded in a GMP-regulated MES environment.

You will map workflows, design MES requirements, and collaborate with manufacturing, quality and MES teams to implement robust, harmonized processes across operations and support go-live readiness and training.

Qualifications

• 10+ years' experience in biopharmaceutical/bioprocess manufacturing, in process engineering or operations leadership.
• Hands-on involvement in MES implementation projects (e.g., PAS-X, Syncade, PharmaSuite, Opcenter).
• Strong understanding of upstream and downstream bioprocess operations.
• Sound knowledge of GMP, batch record practices and data integrity.
• Strong leadership, facilitation and stakeholder management skills.

Responsibilities

• Lead the process workstream of the MES project, from process mapping through go-live.
• Map and analyze bioprocess manufacturing workflows (upstream and downstream) and translate them into MES requirements.
• Partner with manufacturing, quality and MES teams to design MBR / EBR recipes that reflect real shop-floor operations.
• Drive process harmonization and standardization across operations.
• Support testing, validation and user acceptance to make sure solutions meet GMP and operational needs.
• Support operational readiness, training and adoption at go-live.

Skills

Bioprocess manufacturing

Process mapping

Leadership

Stakeholder management

GMP knowledge

Education

B.S. in chemical/biochemical engineering or life sciences

Tools

PAS-X

Syncade

PharmaSuite

Opcenter

Job description

Advanced Manufacturing Tech Solutions seeks a Process Lead to guide the MES project, ensuring bioprocess manufacturing is accurately captured, optimized, and embedded in a GMP-regulated MES environment.

You will map workflows, design MES requirements, and collaborate with manufacturing, quality and MES teams to implement robust, harmonized processes across operations and support go-live readiness and training.