Engineer II- Blood Products

Support manufacturing operations for Blood Products by sustaining and improving production processes, equipment, documentation, capacity, quality, and cost performance. Partner cross-functionally with Quality Engineering, Research and Development, Process Development, Operations, and other functions to resolve manufacturing issues, implement technical changes, and support the transfer of new or modified processes and technologies into manufacturing. Apply validation principles, including IQ/OQ/PQ, and continuous improvement methods to maintain capable, compliant, and efficient production processes.

• Champion a safety-driven culture and comply with applicable safety, environmental, and occupational health requirements.
• Provide day-to-day engineering support for manufacturing processes, production equipment, product flow, and line performance.
• Participate in the timely disposition of nonconformances, root-cause investigations, and corrective and preventive actions related to materials, methods, personnel, equipment, and the manufacturing environment.
• Serve as the manufacturing representative for assigned existing process and product technologies and for new technologies transitioning from Process Development into manufacturing.
• Partner with Operations, Quality Engineering, Research and Development, Process Development, and other functions to address technical issues and support business priorities.
• Plan and implement technical changes needed to sustain production capacity, product quality, process performance, and equipment availability.
• Sustain assigned production equipment in a functionally acceptable state and coordinate technical support to maintain availability for production.
• Create, revise, and maintain manufacturing procedures, routers or routing documentation, bills of materials, and related production documentation so they are accurate, complete, current, and aligned with approved practices.
• Monitor and support achievement of manufacturing metrics, including yield, efficiency, capacity, scrap, and cost performance.
• Conduct detailed time studies and observe production lines, equipment, and product flow to identify constraints and improvement opportunities.
• Lead or execute improvement projects in accordance with applicable business processes to improve quality, increase capacity, reduce scrap, or reduce cost.
• Identify and implement process improvements and author and execute associated validations, protocols, studies, and reports, as applicable.
• Apply validation principles, including installation qualification, operational qualification, and performance qualification, to manufacturing equipment and processes.
• Perform other duties as assigned.

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Biomedical Engineering, or a related field required.
• One to three years of relevant engineering or manufacturing experience required. SPECIALIZED SKILLS & OTHER REQUIREMENTS:
  • Ability to analyze problems and interpret complex scientific and manufacturing processes.
  • Knowledge of process validation and qualification principles; experience with IQ/OQ/PQ and manufacturing validations preferred.
  • Knowledge of Lean principles or other continuous improvement methods preferred.
  • Ability to manage multiple priorities and complete work within tight timelines.
  • Effective written and verbal communication, organization, and interpersonal skills.
  • Strong attention to detail, quality, and documentation accuracy.
  • Ability to take initiative, adapt to changing situations, learn new processes, and prioritize work effectively.
  • Ability to collaborate effectively across technical and operational functions.
  TRAVEL REQUIRED:

  Up to 10%