Manufacturing Engineer II

Katalyst CRO; Saint Paul (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an engineer to help integrate the legacy CSI quality management system into the Client quality management system. The role emphasizes documentation review, protocol execution, and equipment qualification (IQ/OQ/PQ) within the site’s manufacturing environment.

You will support documentation harmonization, validation execution, and contribute to manufacturing engineering initiatives during system integration, ensuring thorough risk management and robust process controls.

Qualifications

• Strong documentation review and execution skills.
• Experience with equipment qualification (IQ/OQ/PQ) preferred.
• Experience with system integration, line move, or duplication preferred.

Responsibilities

• Review procedures documentation and ensure proper execution of protocols and SOPs during site integration.
• Maintain controlled process documentation including work instructions, process flow diagrams, gap analyses, control plans, and risk management docs.
• Apply technical knowledge to support manufacturing engineering activities.
• Lead complex manufacturing engineering tasks involving multiple interrelated elements.
• Identify issues and provide resolution recommendations, including new methods and approaches.
• Consider cross-system impact during problem solving.
• Collaborate with peers for task reviews and validation activities.

Skills

Documentation review

Protocol execution

IQ/OQ/PQ

Manufacturing engineering

System integration

Risk management

Problem solving

Education

BS in Electrical, Software, or Mechanical Engineering

Job description

• The role focuses on integration of the legacy CSI quality management system into the Client quality management system, with an emphasis on documentation review, execution of protocols, and equipment qualification activities (IQ/OQ/PQ).
• The candidate is expected to support documentation harmonization, validation execution, and contribute to manufacturing engineering initiatives during system integration.
• Review documentation of procedures and ensure proper execution of protocols and SOPs as part of the site's integration into Client.
• Support maintenance of controlled process documentation including work instructions, process flow diagrams, gap analysis, control plans, and risk management documentation.
• Apply technical knowledge and understanding of business objectives, manufacturing operations, and company environment to support manufacturing engineering activities.
• Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks involving multiple interrelated elements.
• Anticipate and identify key issues and provide recommendations for resolution, including application of new methods and approaches.
• Consider impact of solutions on other system components during problem resolution.
• Interact with peers and mentors for peer review of task approaches and validation activities, including verification and validation processes.

Job Summary

• The role focuses on integration of the legacy CSI quality management system into the Client quality management system, with an emphasis on documentation review, execution of protocols, and equipment qualification activities (IQ/OQ/PQ).
• The candidate is expected to support documentation harmonization, validation execution, and contribute to manufacturing engineering initiatives during system integration.

Roles & Responsibilities

• Review documentation of procedures and ensure proper execution of protocols and SOPs as part of the site's integration into Client.
• Support maintenance of controlled process documentation including work instructions, process flow diagrams, gap analysis, control plans, and risk management documentation.
• Apply technical knowledge and understanding of business objectives, manufacturing operations, and company environment to support manufacturing engineering activities.
• Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks involving multiple interrelated elements.
• Anticipate and identify key issues and provide recommendations for resolution, including application of new methods and approaches.
• Consider impact of solutions on other system components during problem resolution.
• Interact with peers and mentors for peer review of task approaches and validation activities, including verification and validation processes.

Education & Experience

• Bachelor of Science or Bachelor of Engineering in Electrical, Software, or Mechanical Engineering.
• 35 years of relevant experience.
• Strong documentation review and execution skills with high attention to detail.
• General mechanical engineering knowledge with ability to quickly adapt after training.
• Experience with equipment qualification (IQ/OQ/PQ) preferred.
• Experience with system integration, line move, or duplication preferred.