Manufacturing Engineering Technologist
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-05-28
Listing for:
Harba
Full Time
position Listed on 2026-05-28
Job specializations:
-
Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering, Validation Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Validation Engineer
Job Description & How to Apply Below
Job Responsibilities:
- Resolve issues that arise in the day-to-day operation of manufacturing processes, providing timely responses and effective solutions
- Collaborate with cross-functional technical teams and site leadership to implement process and equipment improvements
- Serve as a Subject Matter Expert (SME) for aseptic filling equipment and supporting manufacturing systems
- Evaluate, maintain, and improve the efficiency and reliability of manufacturing instruments, equipment, and tools
- Support the implementation of new technologies, process enhancements, and operational changes
- Participate in and support Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process and product risks
- Provide hands-on technical support for manufacturing activities, troubleshooting, and preventative maintenance efforts
- Apply Good Engineering Practices (GEP) to support engineering compliance and operational excellence
- Partner with vendors and suppliers to define equipment requirements and review functional specifications
- Support data integrity initiatives and implementation of digital manufacturing technologies
- Maintain ownership of manufacturing equipment tracking systems and related documentation
- Drive continuous improvement initiatives focused on quality, efficiency, and process reliability
- Mentor manufacturing personnel and encourage problem-solving and solution-driven thinking
- Support production schedules through flexible work hours when necessary to ensure facility coverage
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related technical field with 5+ years of relevant experience
- OR 10+ years of relevant manufacturing engineering or technical operations experience
- Experience in pharmaceutical, biologics, medical device, or other highly regulated manufacturing environments
- Knowledge of cGMP manufacturing practices and regulatory requirements
- Experience with aseptic processing, sterile manufacturing, fill-and-finish operations, and process development
- Strong understanding of process controls, instrumentation, electro-mechanical systems, and manufacturing equipment
- Ability to become a Subject Matter Expert (SME) for aseptic filling, inspection, and packaging equipment
- Lean Six Sigma certification preferred
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