Engineer III, Manufacturing Process

Thermo Fisher Scientific•Indianapolis, IN

17d

About The Position

Join Thermo Fisher Scientific’s Clinical Trial Division and help support lifesaving clinical trials. In this role, you will contribute to the packaging and preparation of clinical trial drug products that reach patients around the world. You will work on meaningful projects, partner with supportive teams, and help shape processes that improve quality and patient care. As a Manufacturing Engineer, you will develop equipment qualifications, process documentation, and packaging components such as labels, inserts, and cartons. You will also support manual, semi-automated, and automated packaging processes, including auto-injector systems. This role offers hands-on work, collaboration, and opportunities to innovate. We have 2 positions available. What will you do? Provide technical support that helps maintain safe and consistent production. Build manufacturing processes that increase quality, reliability, and sustainability. Create and test automated solutions that simplify workflows and improve performance. Support installation and integration of automation tools such as PLCs, robotics, and machine-vision systems. Troubleshoot equipment, review data, and identify opportunities for improvement. Partner with operations, quality, and engineering teams to strengthen processes. Lead problem-solving activities, including root-cause analysis and risk-reduction efforts. Write clear documentation, including SOPs, protocols, and study reports. Participate in equipment testing, FATs, SATs, and qualification activities. Support continuous-improvement projects using Lean and Six Sigma practices. Stay current on new technologies that can enhance our systems and workflow.

Requirements

Bachelor’s degree in Mechanical, Electrical, Industrial, Automation, or Manufacturing Engineering.
Minimum 3 years experience in GMP, pharmaceutical, biotech, or regulated manufacturing environments.
Experience with automation systems or process automation in a production setting.
Familiarity with CAD tools such as SolidWorks or AutoCAD.
Experience with statistical analysis or DOE tools (JMP experience is a plus).
Knowledge of automation data integrity and audit trail systems is helpful.
Collaborative communication style and ability to work well with cross-functional teams.
Strong analytical and creative problem-solving skills.
Comfort working with data and making informed, balanced recommendations.
Understanding of Lean or continuous-improvement concepts.
Ability to support several projects and tasks at once.
Attention to detail and an interest in learning new tools and technologies.

Nice To Haves

Experience in biotech or regulated packaging environments.
Familiarity with PLCs, robotics, or machine-vision systems.
Experience in automation assembly or integration.

Responsibilities

Provide technical support that helps maintain safe and consistent production.
Build manufacturing processes that increase quality, reliability, and sustainability.
Create and test automated solutions that simplify workflows and improve performance.
Support installation and integration of automation tools such as PLCs, robotics, and machine-vision systems.
Troubleshoot equipment, review data, and identify opportunities for improvement.
Partner with operations, quality, and engineering teams to strengthen processes.
Lead problem-solving activities, including root-cause analysis and risk-reduction efforts.
Write clear documentation, including SOPs, protocols, and study reports.
Participate in equipment testing, FATs, SATs, and qualification activities.
Support continuous-improvement projects using Lean and Six Sigma practices.
Stay current on new technologies that can enhance our systems and workflow.