Manufacturing Process Engineer - Lean & Validation

Burke Porter, an Ascential Technologies Brand; Ham Lake (MN); On-site; USD 75,000 - 90,000; Full time

Job summary

Burke Porter, an Ascential Technologies Brand, is seeking a manufacturing professional to design, implement, and optimize production processes in a cGMP environment. The role focuses on SOP/MBR development, data analysis, and process validation across equipment and computer systems.

You will lead risk assessments, drive continuous improvement with lean and Six Sigma methodologies, train staff, prepare change controls and CAPAs, and support commissioning, qualification, and validation activities

Qualifications

• Experience with cGMP manufacturing and validation projects.
• Ability to perform risk assessments and FMEA.
• Experience developing SOPs and MBRs.
• Strong troubleshooting and data analysis skills.

Responsibilities

• Assist in design, implementation, and optimization of manufacturing processing.
• Develop and maintain SOPs, MBRs, and work instructions.
• Monitor production data to identify trends and opportunities for improvement.
• Support validation projects for equipment and software, including commissioning and qualification.
• Assist in training production personnel on new equipment and processes.

Skills

Lean manufacturing

Six Sigma

FMEA

Troubleshooting

Job description

Burke Porter, an Ascential Technologies Brand, is seeking a manufacturing professional to design, implement, and optimize production processes in a cGMP environment. The role focuses on SOP/MBR development, data analysis, and process validation across equipment and computer systems.

You will lead risk assessments, drive continuous improvement with lean and Six Sigma methodologies, train staff, prepare change controls and CAPAs, and support commissioning, qualification, and validation activities