Manufacturing Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 75,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Engineer to support pharmaceutical manufacturing operations in Indianapolis, IN. The role focuses on designing, troubleshooting, optimizing, and maintaining critical utility systems such as HVAC, chilled water, steam, compressed air, and process gases.

The position requires collaboration with cross-functional teams to ensure reliable, compliant, and energy-efficient facility operations within a GMP/cGMP-regulated environment.

Qualifications

• Experience in pharmaceutical or life sciences industry.
• Hands-on work in GMP/cGMP-regulated environments.
• Proficiency in AutoCAD and engineering documentation.

Responsibilities

• Design, troubleshoot, optimize, and maintain utility systems (HVAC, chilled water, steam, compressed air, process gases).
• Support pharmaceutical manufacturing facilities to ensure reliable and energy-efficient utility operations.
• Develop and review P&IDs, engineering calculations, and equipment specifications.
• Provide technical support during project design, installation, commissioning, qualification, and startup activities.
• Conduct root-cause analysis and implement corrective and preventive maintenance solutions.
• Collaborate with operations, maintenance, engineering, and project teams to minimize downtime and improve system performance.
• Ensure compliance with cGMP, FDA/EMA regulations, safety standards and engineering best practices.
• Support equipment troubleshooting, maintenance planning, and continuous improvement initiatives.
• Utilize AutoCAD for engineering drawings and documentation updates.

Skills

HVAC

Chilled water

Steam

Compressed air

Process gases

AutoCAD

Education

Bachelor's degree in Mechanical Engineering, Chemical Engineering, or Industrial Engineering

Tools

AutoCAD

Job description

• We are seeking a Manufacturing Engineer to support pharmaceutical manufacturing operations in Indianapolis, IN.
• The ideal candidate will be responsible for designing, troubleshooting, optimizing, and maintaining critical utility systems such as HVAC, chilled water, steam, compressed air, and process gases.
• This role requires collaboration with cross-functional teams to ensure reliable, compliant, and energy-efficient facility operations within a GMP/cGMP-regulated pharmaceutical environment.
• Design, troubleshoot, optimize, and maintain utility systems including HVAC, chilled water, steam, compressed air, and process gases.
• Support pharmaceutical manufacturing facilities by ensuring reliable and energy-efficient utility operations.
• Develop and review P&IDs, engineering calculations, and equipment specifications.
• Provide technical support during project design, installation, commissioning, qualification, and startup activities.
• Conduct root-cause analysis and implement corrective and preventive maintenance solutions.
• Collaborate with operations, maintenance, engineering, and project teams to minimize downtime and improve system performance.
• Ensure compliance with cGMP, FDA/EMA regulations, safety standards, and engineering best practices.
• Support equipment troubleshooting, maintenance planning, and continuous improvement initiatives.
• Utilize AutoCAD for engineering drawings and documentation updates.

Job Summary

• We are seeking a Manufacturing Engineer to support pharmaceutical manufacturing operations in Indianapolis, IN.
• The ideal candidate will be responsible for designing, troubleshooting, optimizing, and maintaining critical utility systems such as HVAC, chilled water, steam, compressed air, and process gases.
• This role requires collaboration with cross-functional teams to ensure reliable, compliant, and energy-efficient facility operations within a GMP/cGMP-regulated pharmaceutical environment.

Roles & Responsibilities

• Design, troubleshoot, optimize, and maintain utility systems including HVAC, chilled water, steam, compressed air, and process gases.
• Support pharmaceutical manufacturing facilities by ensuring reliable and energy-efficient utility operations.
• Develop and review P&IDs, engineering calculations, and equipment specifications.
• Provide technical support during project design, installation, commissioning, qualification, and startup activities.
• Conduct root-cause analysis and implement corrective and preventive maintenance solutions.
• Collaborate with operations, maintenance, engineering, and project teams to minimize downtime and improve system performance.
• Ensure compliance with cGMP, FDA/EMA regulations, safety standards and engineering best practices.
• Support equipment troubleshooting, maintenance planning, and continuous improvement initiatives.
• Utilize AutoCAD for engineering drawings and documentation updates.

Experience

• Experience in the pharmaceutical or life sciences industry required
• Hands-on experience working in GMP/cGMP-regulated environments
• Strong background in utility systems and/or facilities engineering
• Experience with commissioning, qualification, troubleshooting, and maintenance activities
• Proficiency in AutoCAD and engineering documentation
• Mid/Junior Level: 2-7 years of relevant experience
• Senior Level: 8+ years of relevant experience

Education:

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or related engineering discipline preferred