Associate Manufacturing Engineer

Titan, Inc; Ham Lake, Northern (MN, KY); Hybrid; USD 75,000 - 90,000; Full time

Job summary

Ascential Medical & Life Sciences in Ham Lake, MN 55304, USA, is seeking a manufacturing specialist to design, implement, and optimize processing steps. The role focuses on SOP and MBR maintenance, risk assessment, and constant improvement of production efficiency and safety.

Responsibilities include data monitoring, troubleshooting, and supporting validation projects for equipment and computerized systems, with emphasis on GMP compliance and process validation activities.

Qualifications

• Develop and maintain Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
• Participate in continuous improvement initiatives such as lean manufacturing and Six Sigma methodologies.
• Validation and implementation of manufacturing equipment and computer system/software validations.
• Assist in risk assessment on process steps and their ability to meet requirements.

Responsibilities

• Participates in and supports design, implementation, and optimization of manufacturing processing.
• Identify trends and opportunities for improvement by monitoring production data.
• Improve efficiency, safety, and compliance of processes and equipment.
• Provide technical support for troubleshooting equipment and process deviations.
• Assist in training production personnel on new equipment and processes.

Skills

SOP development

MBR creation

Lean manufacturing

Six Sigma

CAPA handling

Validation

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
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