Associate Manufacturing Engineer — Process Improvement & Validation

Nacs,-Inc.; Ham Lake (MN); On-site; USD 75,000 - 90,000; Full time

Job summary

Ascential Medical & Life Sciences in Ham Lake, MN is seeking a hands-on Manufacturing Process Engineer to design, implement, and optimize manufacturing processing in a cGMP environment.

You will develop and maintain SOPs, Master Batch Records, and work instructions, monitor production data for trends, and drive continuous improvements using lean and Six Sigma methodologies. You will also participate in validations and CAPAs to ensure quality and compliance.

Qualifications

• Experience with SOPs, MBRs, and work instructions development.
• Knowledge of lean manufacturing and Six Sigma methodologies.
• Ability to perform risk assessments and root cause analysis.
• Experience with validation projects for equipment and computerized systems.

Responsibilities

• Participates in design, implementation, and optimization of manufacturing processes.
• Develop and maintain SOPs, MBRs, and work instructions.
• Monitor production data to identify trends and opportunities.
• Improve efficiency, safety, and compliance.
• Support validation of equipment and computer systems.
• Prepare change controls, CAPAs, and investigations.
• Assist in training production staff on new equipment.
• Apply FMEA to evaluate failure data and root causes.

Skills

Lean manufacturing

Six Sigma

SOPs

MBRs

CAPAs

GMP

Root cause analysis

Validation

Computerized systems

Tools

Computerized systems

Job description

Ascential Medical & Life Sciences in Ham Lake, MN is seeking a hands-on Manufacturing Process Engineer to design, implement, and optimize manufacturing processing in a cGMP environment.

You will develop and maintain SOPs, Master Batch Records, and work instructions, monitor production data for trends, and drive continuous improvements using lean and Six Sigma methodologies. You will also participate in validations and CAPAs to ensure quality and compliance.