Job Title: Manufacturing Engineer

Job Description

A Manufacturing Engineer in this role focuses on designing, planning, and implementing validated manufacturing systems and equipment improvements within an FDA/cGMP/OTC environment. Their day involves routine equipment checks, process improvement initiatives, and collaboration with Quality and Validation teams to ensure compliance. They also work on project planning and implementation, attend cross-functional meetings, and document progress. The most important aspect is their hands-on approach and ability to lead continuous improvement activities in a team setting.

Responsibilities

• Design, plan, and implement validated manufacturing systems and equipment improvements within an FDA/cGMP/OTC environment.
• Conduct routine equipment checks and initiate process improvement activities.
• Collaborate with Quality and Validation teams to ensure compliance.
• Lead continuous improvement projects as a leader and facilitator.
• Attend cross-functional meetings and document progress.
• Utilize problem-solving techniques such as 8D, Six Sigma, DOE, and SPC.
• Apply lean manufacturing principles including visual management, 5S, and PDCA.
• Work with blending, filling, packaging, or automated equipment.
• Equipment validation support (IQ/OQ/PQ)
• Demonstrate proficiency using CAD software (AutoCAD/SolidWorks).
• Troubleshoot and modify PLC programs.

Essential Skills

• Demonstrated Continuous Improvement project experience as a leader and facilitator.
• Excellent communication skills, both written and verbal.
• Proficient in Microsoft Office applications, including Word, Excel, PPT.
• Project management experience.
• Problem-solving experience or training (8D, Six Sigma, DOE, SPC).
• Lean manufacturing experience (Visual management, 5S, PDCA).
• Continuous Improvement experience in a Manufacturing Environment.
• Experience in an OTC or FDA controlled environment.
• Experience with blending, filling, packaging, or automated equipment.
• Proficiency using CAD software (AutoCAD/SolidWorks).

Additional Skills & Qualifications

• Bachelor's degree in Manufacturing, Mechanical, or Process Engineering.
• 5+ years of applicable experience.
• PLC experience troubleshooting and program modification highly desirable.
• Hands on fabrication ability highly desirable

Work Environment

This position is required to be onsite full time. The work environments described here are representative of those an employee encounters while performing the essential functions of this job onsite. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. The facility is a beautiful new location in Franklin, WI.