Associate Manufacturing Engineer – Process Improvement & Validation

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 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.