Associate Manufacturing Engineer
Burke Porter, an Ascential Technologies Brand•Andover, MN
•$75,000 - $90,000
About The Position
The Associate Manufacturing Engineer supports the design, implementation, and optimization of manufacturing processes in cGMP-regulated manufacturing areas. The role develops and maintains manufacturing documentation, analyzes production data, improves process efficiency and compliance, and provides technical support for equipment and process issues. It also supports equipment and computerized system validation projects, including preparation and execution of commissioning, qualification, and validation documentation, with guidance from management.
Responsibilities
- 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 in existing and new processes.
- Participate in continuous improvement initiatives, including lean manufacturing and Six Sigma methodologies.
- Validate and implement manufacturing equipment and computerized systems or software.
- Conduct risk assessments of process steps and their ability to meet requirements.
- Analyze and plan workflow, space requirements, and equipment layout to improve manufacturing efficiency.
- Identify and resolve technical issues affecting manufacturing performance.
- Provide technical support for troubleshooting equipment and process-related deviations.
- Assist in training production personnel on new equipment and processes.
- Prepare and issue change controls, CAPAs, and investigations.
- Prepare, review, and execute commissioning, qualification, and validation documents for equipment and computerized systems or software.
- Support project teams with User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
- Manage multiple commissioning, qualification, and validation priorities based on manufacturing-area and project-team needs, with guidance from management.
- Assist with troubleshooting equipment and computer-system issues, process characterization, and root-cause investigations.
- Help resolve deviations and non-conformances identified during qualification and validation activities.
- Apply FMEA to evaluate failure data, when necessary, identify root causes, and implement engineering solutions.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
