Sr. Principal - Scientist QC - Analytical Equipment Support

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The Analytical Equipment Support Group (AESG) Scientist provides technical leadership and expertise for analytical instrumentation. The role focuses on maintaining advanced analytical equipment, ensuring accuracy and reliability of data, and collaborating with cross-functional teams to develop engineering solutions for QC instrumentation. The scientist reviews protocols and reports and shares technical information and best practices within the group.

Location:

Houston, TX.

• Manage and maintain advanced analytical equipment, ensuring optimal performance and reliability.
• Collaborate with cross-functional teams to integrate analytical findings into practical applications.
• Troubleshoot and resolve equipment issues, performing routine maintenance, calibration and qualification activities.
• Design and implement engineering improvements to enhance equipment performance and efficiency.
• Stay updated with the latest advancements in analytical equipment, methodologies, and engineering practices.
• Ensure compliance with all relevant regulations and standards.
• Manage comprehensive equipment life cycle.
• Represent Lilly Houston in Global Lab Equipment Network.
• Adhere to global quality standards related to computer systems.
• Identify systemic issues affecting analytical testing in QC.
• Research and recommend new technologies.
• Serve as a technical mentor for Scientists and Technicians within and outside QC.
• Work with both internal and external organizations in instrument selection, usage, and troubleshooting.
• Coordinate with lab SMEs for procurement, set-up, and validation of lab equipment.
• Create maintenance work instructions and establish engineering controls.
• Manage the drafting and review of cGMP documents.
• Manage/Develop maintenance strategies and author qualification protocols.
• Participate in self-assessments and regulatory inspections/audits.
• Provide technical review and Second Person Verification (SPV).
• Maintain and improve quality systems.
• Provide technical support to non-routine investigations, including preparation of relevant technical documents (Change Controls, Analytical Investigations, Validation Protocols, Procedures, and Quality System Management Review).

• Required:
  
  Bachelor's degree in chemistry or engineering (preferred) with 1+ year of experience in a GMP-regulated environment.
• Required:
  
  10+ years of experience managing maintenance, analytical equipment, or a similar role in a GMP-regulated environment.
• Required:
  
  Authorized to work in the United States on a full-time basis;
  Lilly will not sponsor work authorization or visas for this role.
• Preferred:
  Experience in engineering, maintenance, or technical support roles.
• Preferred:
  Technical expertise in analytical equipment functionality.
• Preferred:
  Demonstrated scientific and technical expertise; teamwork and interpersonal skills; decision making; multi-tasking; ability to prioritize; complex instrumentation problem solving.
• Preferred:
  Experience in a GMP/GLP environment and troubleshooting equipment issues.
• Preferred:
  Familiarity with spectroscopy, chromatography, and mass spectrometry.
• Preferred:
  Publications in peer-reviewed scientific journals.
• Preferred:
  Project management and leadership experience.
• Preferred:
  Knowledge of engineering principles and practices related to analytical equipment; strong knowledge of analytical principles, methodologies, and engineering practices; excellent analytical and problem-solving skills; ability to work independently and as part of a team; strong communication and presentation skills; proficiency in relevant software and tools.

• Bachelor’s degree in chemistry or engineering (preferred).

• Technical leadership for analytical instrumentation
• Troubleshooting, routine maintenance, calibration and qualification of analytical equipment
• Engineering design and improvement of equipment performance
• Cross-functional collaboration and integration of analytical findings
• Technical review of protocols and reports; mentorship within QC
• Knowledge of cGMP, GLP, and quality systems; instrument selection, procurement, setup, validation
• Familiarity with spectroscopy, chromatography, and mass spectrometry
• Project management and leadership
• Strong analytical, problem-solving, and communication skills
• Proficiency in scientific and engineering software/tools