Process Engineer

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

Job Description

The Process Engineer II supports manufacturing operations by optimizing production processes, implementing process improvements, and ensuring compliance with quality and regulatory standards. This role partners closely with Operations, Quality, Maintenance, and Engineering teams to improve efficiency and product reliability.

Roles & 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.

Job Description

The Process Engineer II supports manufacturing operations by optimizing production processes, implementing process improvements, and ensuring compliance with quality and regulatory standards. This role partners closely with Operations, Quality, Maintenance, and Engineering teams to improve efficiency and product reliability.

Roles & 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.

Requirements

• 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.
• Bachelor's Degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering.

Mandatory Skills / Competencies

• GMP Compliance
• Process Validation
• Root Cause Analysis
• CAPA
• Technical Documentation
• Data Analysis
• Cross-functional Collaboration
• Problem Solving