What are the responsibilities and job description for the Manufacturing Engineer position at Katalyst CRO?
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.
- 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 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
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or related engineering discipline preferred