Principal Associate Quality Assurance - FUME
Eli Lilly and Company
June 27, 2026
On-site
Houston, TX
Operations
Responsibilities:
- Provide oversight to Houston facilities, utilities, maintenance, and equipment.
- Ensure GMP compliance in the design, delivery, verification, qualification, and startup to support regulatory approval.
- Provide quality oversight for commissioning/qualification documentation (URS, test cases, protocols, discrepancies resolution, traceability matrix, summary reports, periodic reviews).
- Provide C&Q/Verification & Validation oversight, including automation and computer systems validation.
- Perform technical and quality review/approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures.
- Review/redline documents to ensure quality attributes are met (deviations/observations, procedures, technical studies, validation protocols, change controls, engineering documents).
- Support site readiness planning and ongoing quality oversight for site FUME systems; participate in Utilities Process Team and Business QA for local computer systems.
- Support inspection readiness for internal/external regulatory inspections related to facilities, utilities, equipment, and maintenance.
- Contribute to and review asset qualification maintenance strategies and periodic reviews.
- Participate in continuous improvement projects and foster a quality culture.
- Adhere to safety rules and maintain a safe work environment.
Basic Qualifications:
- Bachelor’s degree in engineering or science-related field (or equivalent experience).
- Minimum 5 years in pharmaceutical GMP QA roles.
- Previous pharmaceutical FUME experience.
Additional Skills/Preferences:
- Organize/prioritize multiple tasks; QA/TS-MS QC or engineering experience.
- Facility/area startup experience.
- GMP utilities experience (WFI, clean steam, process compressed air).
- Deviation/CAPA/change control experience; root cause analysis.
- Knowledge of US/EU/Japan and other facility/utility/equipment regulations.
- Strong oral/written communication, problem-solving, analytical skills, and attention to detail.
- Proficiency with tools (e.g., KNEAT, Veeva, TrackWise, SAP, GMARS); understanding statistical tools.
Additional Information:
- Work 8-hour days, Monday–Friday.
- Use safety gear and follow site-specific safety requirements.
Work Authorization:
- Must be authorized to work in the US full-time; Lilly does not sponsor visas.
- Provide oversight to Houston facilities, utilities, maintenance, and equipment.
- Ensure GMP compliance in the design, delivery, verification, qualification, and startup to support regulatory approval.
- Provide quality oversight for commissioning/qualification documentation (URS, test cases, protocols, discrepancies resolution, traceability matrix, summary reports, periodic reviews).
- Provide C&Q/Verification & Validation oversight, including automation and computer systems validation.
- Perform technical and quality review/approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures.
- Review/redline documents to ensure quality attributes are met (deviations/observations, procedures, technical studies, validation protocols, change controls, engineering documents).
- Support site readiness planning and ongoing quality oversight for site FUME systems; participate in Utilities Process Team and Business QA for local computer systems.
- Support inspection readiness for internal/external regulatory inspections related to facilities, utilities, equipment, and maintenance.
- Contribute to and review asset qualification maintenance strategies and periodic reviews.
- Participate in continuous improvement projects and foster a quality culture.
- Adhere to safety rules and maintain a safe work environment.
Basic Qualifications:
- Bachelor’s degree in engineering or science-related field (or equivalent experience).
- Minimum 5 years in pharmaceutical GMP QA roles.
- Previous pharmaceutical FUME experience.
Additional Skills/Preferences:
- Organize/prioritize multiple tasks; QA/TS-MS QC or engineering experience.
- Facility/area startup experience.
- GMP utilities experience (WFI, clean steam, process compressed air).
- Deviation/CAPA/change control experience; root cause analysis.
- Knowledge of US/EU/Japan and other facility/utility/equipment regulations.
- Strong oral/written communication, problem-solving, analytical skills, and attention to detail.
- Proficiency with tools (e.g., KNEAT, Veeva, TrackWise, SAP, GMARS); understanding statistical tools.
Additional Information:
- Work 8-hour days, Monday–Friday.
- Use safety gear and follow site-specific safety requirements.
Work Authorization:
- Must be authorized to work in the US full-time; Lilly does not sponsor visas.