Location: Indianapolis, IN

Job Summary

The Sr. Quality Engineer will work cross-functionally to develop and implement engineering solutions that enhance compliance and reliability. This position will be responsible for providing quality oversight on the execution and update of the Validation Master Plan and site metrics. This position provides guidance on CAPA plans and use statistical tools to identify trends and promote continuous improvement. The Sr. Quality Engineer will be responsible for leading root cause analysis efforts using risk management principles. Supporting a Multi-phase to commercial facility. This position reports directly to the Associate Director, of Quality, Indianapolis.

Job Responsibilities

• Provide quality support and oversight of equipment validation, computer systems validation, and change management.
• Provide quality review and support for the calibration and preventive maintenance programs.
• Lead continuous improvement initiatives through cross-functional support and project management techniques.
• Participate with the Facilities, Engineering and MS&T teams on new installations/systems and innovation.
• Leads cross-functional efforts for process improvement projects through use of statistical tools and various risk analysis tools.
• Apply current industry standards and regulations to ensure procedures and policies are compliant with FDA, EU and ISPE GAMP-5 guidelines.
• Support the enrollment and approval of assets in the asset management system.
  
  

Education And Experience

• BS/MS in Science related discipline preferred with 5-6+ years of quality assurance or quality engineering experience
• Experience working in a GMP aseptic manufacturing environment preferred
• Experience working with FDA and EU regulations.
• ASQ or ISO certification and previous auditing experience a plus
  
  

Skills And Qualifications

• Highly motivated and organized professional with the ability to work independently
• Working knowledge of 21 CFR Parts 11, 210, 211 and EU annex
• Very personable with strong communication skills
• Ability to read and interpret technical documents
• Excellent professional ethics, integrity, and ability to maintain confidential information
  
  

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

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