Bachelor's degree in Electrical, Software, or Mechanical Engineering
3-5 years of relevant experience
Strong documentation review skills and attention to detail
General mechanical engineering knowledge with adaptability after training
Preferred experience with equipment qualification (IQ/OQ/PQ)
Preferred experience with system integration, line moves, or duplication
Responsibilities
Review and execute protocols and SOPs for site integration
Maintain controlled process documentation including work instructions and flow diagrams
Apply technical knowledge to support manufacturing engineering initiatives
Lead and own complex manufacturing engineering tasks
Anticipate issues and recommend solutions using new methods
Consider impact of solutions on interconnected system components
Collaborate for peer review of validation activities
Benefits
Opportunity to work on cutting-edge manufacturing integration
Engagement in cross-functional team interactions
Professional growth in a fast-paced environment
Contribution to critical engineering initiatives
Flexible work schedule options available
Full Job Description
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.
3-5 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.
