Process Engineer II: Drive GMP-Driven Manufacturing Improvements

Katalyst CRO; Bloomington (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Process Engineer II to optimize production processes within pharmaceutical manufacturing, collaborating with Operations, Quality, Maintenance, and Engineering teams to improve efficiency and reliability.

The role requires extensive manufacturing/process engineering experience, knowledge of Lean principles, and expertise in process validation and CAPA workflows to ensure GMP and FDA compliance across projects.

Qualifications

• 35 years of manufacturing or process engineering experience.
• Experience in pharmaceutical, biotechnology, or medical device industries.
• Knowledge of Lean Manufacturing principles.
• Experience with process validation activities.

Responsibilities

• Support daily manufacturing operations and troubleshoot process issues.
• Analyze production data to identify process improvement opportunities.
• Develop and update manufacturing procedures and work instructions.
• Lead process validation and equipment qualification activities.
• Collaborate with Quality on deviation investigations and CAPAs.
• Monitor KPIs and recommend corrective actions.
• Support technology transfer and new product introductions.
• Participate in risk assessments and continuous improvement initiatives.
• Ensure compliance with GMP, FDA, and company policies.
• Provide technical support to manufacturing personnel.

Skills

GMP Compliance

Process Validation

Root Cause Analysis

CAPA

Technical Documentation

Data Analysis

Cross-functional Collaboration

Problem Solving

Education

Bachelor's Degree in Chemical/Mechanical/Industrial/Manufacturing Engineering

Job description

Katalyst CRO is seeking a Process Engineer II to optimize production processes within pharmaceutical manufacturing, collaborating with Operations, Quality, Maintenance, and Engineering teams to improve efficiency and reliability.

The role requires extensive manufacturing/process engineering experience, knowledge of Lean principles, and expertise in process validation and CAPA workflows to ensure GMP and FDA compliance across projects.