Manufacturing Associate

Katalyst CRO; Santa Clara (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Santa Clara, CA is seeking a production operations leader to manage daily activities, ensure readiness across cross-functional teams, and drive continuous improvement in manufacturing processes.

The role requires expertise in MES/SAP, Power BI reporting, and GMP/GDP compliance, with a focus on scheduling, inventory control, and scale-up planning.

Qualifications

• 5+ years in manufacturing operations or production control
• Experience with MES and SAP/ERP systems
• Proficient in Power BI and operational reporting
• Strong Excel and Microsoft Office skills
• Experience leading cross-functional teams and presenting metrics to leadership
• Knowledge of GMP, GDP, ISO 13485, and FDA-regulated environments
• Lean/Six Sigma or Operational Excellence experience preferred
• Degree in supply chain, Manufacturing, Operations, Business, or related field
• Experience with Compliance Wire, Air table, SAP/ERP, MES, and Power BI
• Background in production planning, inventory reconciliation, and process improvement initiatives

Responsibilities

• Manage daily production activities and prioritize orders using MES and SAP/ERP
• Coordinate with cross-functional teams to ensure readiness and resolve issues
• Lead production meetings and communicate status, risks, and mitigation plans
• Ensure schedule adherence, inventory accuracy, material availability, and execution
• Support MES, SAP, Power BI reporting, quality systems, and production activities
• Manage inventory replenishment, kitting, staging, and Kanban processes
• Analyze manufacturing data and drive process improvements and productivity
• Standardize processes, work instructions, reports, and training materials
• Mentor team members and support scale-up and capacity planning
• Ensure compliance with ISO 13485, FDA QSR, GMP, GDP, and company standards

Skills

MES/ERP systems

Power BI reporting

Excel / Office tools

Cross-functional leadership

Data analysis & problem solving

Lean Manufacturing / Six Sigma

Communication & mentoring

Education

Bachelor's or Associate degree in supply chain, manufacturing, operations, or related field

Tools

MES

SAP/ERP

Power BI

Job description

• Manage daily production activities and prioritize production/rework orders using MES and SAP/ERP systems.
• Coordinate with cross-functional teams to ensure production readiness and resolve operational issues.
• Lead production meetings and communicate production status, risks, and mitigation plans.
• Ensure schedule adherence, inventory accuracy, material availability, and production execution.
• Support MES, SAP, Power BI reporting, quality systems, and production support activities.
• Manage inventory replenishment, kitting, staging, and Kanban processes.
• Analyze manufacturing data and drive process improvements, operational efficiency, and productivity gains.
• Standardization of processes, work instructions, reports, and training materials.
• Mentor team members and support production scale-up and capacity planning.
• Ensure compliance with ISO 13485, FDA QSR, GMP, GDP, and company standards.

Roles & Responsibilities

• Manage daily production activities and prioritize production/rework orders using MES and SAP/ERP systems.
• Coordinate with cross-functional teams to ensure production readiness and resolve operational issues.
• Lead production meetings and communicate production status, risks, and mitigation plans.
• Ensure schedule adherence, inventory accuracy, material availability, and production execution.
• Support MES, SAP, Power BI reporting, quality systems, and production support activities.
• Manage inventory replenishment, kitting, staging, and Kanban processes.
• Analyze manufacturing data and drive process improvements, operational efficiency, and productivity gains.
• Standardization of processes, work instructions, reports, and training materials.
• Mentor team members and support production scale-up and capacity planning.
• Ensure compliance with ISO 13485, FDA QSR, GMP, GDP, and company standards.

Requirements :

• High School diploma or equivalent with 5+ years of manufacturing operations, production control, materials management, supply chain, logistics, manufacturing systems, operations leadership, or related operational experience.
• Manufacturing operations and production control
• Inventory and material management
• MES and SAP/ERP systems
• Power BI and operational reporting
• Microsoft Excel and Office tools
• Experience leading operations, coordinating cross-functional teams, and presenting performance metrics to leadership.
• Knowledge of GMP, GDP, ISO 13485, and FDA-regulated environments.
• Strong analytical, problem-solving, communication, mentoring, and continuous improvement skills.
• Associate or bachelor's degree in supply chain, Manufacturing, Operations, Business, or related fields.
• Experience with Compliance Wire, Air table, SAP/ERP, MES, and Power BI.
• Background in production planning, inventory reconciliation, manufacturing systems, and process improvement initiatives.
• Lean Manufacturing, Six Sigma, or Operational Excellence Experience preferred.