Associate Manufacturing Engineer

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
Ham Lake, MN 55304, USA

Description

• Participates in and supports the design, implementation, and optimization of manufacturing processing including but not limited to:
• Develop and maintain Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
• Monitor and analyze production data to identify trends and opportunities for improvement.
• Improve efficiency, safety, and compliance, including existing and new processes.
• Participate in continuous improvement initiatives such as lean manufacturing and Six Sigma methodologies.
• Validation and implementation of manufacturing equipment and computer system/software validations.
• Conduct risk assessment on process steps and their ability to meet requirements.
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Identify and resolve technical issues impacting manufacturing performance.
• Provide technical support for troubleshooting equipment and process-related deviations.
• Assist in training production personnel on new equipment and processes.
• Ability to prepare/issue change controls, CAPAs, and investigations.
• Participates in and supports validation projects within the cGMP regulated manufacturing areas, including but not limited to:
  • Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
  • Supporting Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
  • Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
  • Assisting in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
  • Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
  • Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.

Salary range: $75,000 - $90,000 annually

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.