Harba Solutions Inc.
Senior Process Engineer, Automated Visual Inspection
Location: Indianapolis, IN
Salary: $63,000 - $93,000
Employment Type: Full‑time
Job Function: Engineering, Manufacturing, and Science
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Responsibilities
Lead development, optimization, and lifecycle management of automated visual inspection (AVI) systems for injectable or combination product manufacturing.
Create and optimize inspection recipes and vision applications across various product formats.
Install, configure, calibrate, and troubleshoot vision system hardware and software, including cameras, lenses, illumination, and imaging tools.
Drive capital projects involving design, procurement, installation, commissioning, and qualification of AVI equipment.
Conduct performance testing, validation activities, and ongoing system verification after maintenance or modifications.
Analyze inspection and manufacturing data to identify trends, reduce defects, and support continuous improvement.
Apply structured problem‑solving (DMAIC, root cause analysis) and participate in process FMEAs to assess risk and support process validation.
Investigate and resolve complex equipment and process‑related issues, ensuring compliance and minimal impact to routine operations.
Collaborate with internal teams, customers, and vendors to define requirements, manage technical deliverables, and introduce new technologies.
Prepare and execute technical documentation including protocols, reports, validation packages, and lifecycle records.
Support audit responses and regulatory inspections pertaining to visual inspection systems.
Mentor and train team members on AVI technologies and inspection processes.
Work flexible hours as needed to support production operations.
Qualifications
Bachelor’s degree or higher in Engineering (Chemical, Mechanical, Electrical, Biomedical), Physics, Industrial Computer Science, or a related technical field.
5+ years of hands‑on experience with automated visual inspection systems in a GMP or other regulated manufacturing environment.
Strong understanding of vision system fundamentals: optics, lighting, lenses, sensors, image analysis, and system calibration.
Proficiency with platforms such as Keyence, Cognex, or similar industrial vision technologies.
Ability to diagnose and resolve complex hardware and software issues within vision systems.
Experience developing inspection recipes and improving detection accuracy through parameter optimization.
Knowledge of industry inspection standards and regulatory expectations (FDA, EMA, ICH).
Proven ability to execute equipment qualification, process validation, and technology transfer activities.
Experience leading cross‑functional technical teams and managing capital or equipment‑installation projects.
Working knowledge of machine learning concepts for defect detection (preferred but not required).
Experience with Lean, Six Sigma, structured problem solving, or data‑driven methodologies.
Familiarity with data management tools and reliability‑centered maintenance (RCM).
Experience in CMO/CDMO or contract manufacturing environments (preferred).
Strong analytical, troubleshooting, and technical writing skills.
Excellent communication and collaboration abilities with internal teams, customers, and vendors.
Experience supporting regulatory inspections or preparing audit documentation.
Ability to work in a dynamic environment and adapt to shifting manufacturing needs.
Benefits
Medical insurance
Vision insurance
401(k)
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Salary: $63,000 - $93,000
Employment Type: Full‑time
Job Function: Engineering, Manufacturing, and Science
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Responsibilities
Lead development, optimization, and lifecycle management of automated visual inspection (AVI) systems for injectable or combination product manufacturing.
Create and optimize inspection recipes and vision applications across various product formats.
Install, configure, calibrate, and troubleshoot vision system hardware and software, including cameras, lenses, illumination, and imaging tools.
Drive capital projects involving design, procurement, installation, commissioning, and qualification of AVI equipment.
Conduct performance testing, validation activities, and ongoing system verification after maintenance or modifications.
Analyze inspection and manufacturing data to identify trends, reduce defects, and support continuous improvement.
Apply structured problem‑solving (DMAIC, root cause analysis) and participate in process FMEAs to assess risk and support process validation.
Investigate and resolve complex equipment and process‑related issues, ensuring compliance and minimal impact to routine operations.
Collaborate with internal teams, customers, and vendors to define requirements, manage technical deliverables, and introduce new technologies.
Prepare and execute technical documentation including protocols, reports, validation packages, and lifecycle records.
Support audit responses and regulatory inspections pertaining to visual inspection systems.
Mentor and train team members on AVI technologies and inspection processes.
Work flexible hours as needed to support production operations.
Qualifications
Bachelor’s degree or higher in Engineering (Chemical, Mechanical, Electrical, Biomedical), Physics, Industrial Computer Science, or a related technical field.
5+ years of hands‑on experience with automated visual inspection systems in a GMP or other regulated manufacturing environment.
Strong understanding of vision system fundamentals: optics, lighting, lenses, sensors, image analysis, and system calibration.
Proficiency with platforms such as Keyence, Cognex, or similar industrial vision technologies.
Ability to diagnose and resolve complex hardware and software issues within vision systems.
Experience developing inspection recipes and improving detection accuracy through parameter optimization.
Knowledge of industry inspection standards and regulatory expectations (FDA, EMA, ICH).
Proven ability to execute equipment qualification, process validation, and technology transfer activities.
Experience leading cross‑functional technical teams and managing capital or equipment‑installation projects.
Working knowledge of machine learning concepts for defect detection (preferred but not required).
Experience with Lean, Six Sigma, structured problem solving, or data‑driven methodologies.
Familiarity with data management tools and reliability‑centered maintenance (RCM).
Experience in CMO/CDMO or contract manufacturing environments (preferred).
Strong analytical, troubleshooting, and technical writing skills.
Excellent communication and collaboration abilities with internal teams, customers, and vendors.
Experience supporting regulatory inspections or preparing audit documentation.
Ability to work in a dynamic environment and adapt to shifting manufacturing needs.
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr