Engineer - Quality - FUME

Role Summary

Engineer - Quality - FUME at Lilly. Provides oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment (FUME) to maintain GMP compliance and ensure inspection readiness. This role supports the growth of Lilly’s manufacturing footprint and focuses on quality assurance for FUME-related activities.

Responsibilities

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Leads, mentors, and coaches operations and support personnel on FUME quality matters.
• Acts as a QA SME, collaborating with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and service provider firms to design areas using QbD and QRM principles and integrate Lilly Global Quality System requirements into facilities, assets, and systems.
• Provides technical and quality review and approval of facility, utility, and equipment system documents to ensure compliance with Lilly Global Quality Standards and project procedures.
• Provides quality oversight for verification and qualification of facility, utility, and equipment systems, including review of test cases, execution, summaries, and discrepancy resolution.
• Provides QA oversight of maintenance activities including initial calibrations and maintenance plan development.
• Provides mentorship and QA oversight for change management, QRM, process validation and equipment validation efforts.
• Works with site quality to develop the vision and strategy for the overall site quality operation with focus on FUME areas.
• Supports the site organization in building technical capability across Quality, project teams, and area process teams, including mentoring of new staff.
• Fosters a strong quality culture with open communication and teamwork; promotes participation in work groups.
• Leads project initiatives for site continuous improvement, expansion, and Quality function.
• Resolves or escalates compliance issues to project lead, site leadership, and Quality Management.
• Supports the QA Compliance team and site in site readiness for start-up and ongoing quality oversight of FUME systems, including work with Utilities Process Team and Business Quality Assurance for local computer systems.

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical-related field or equivalent experience.
• Minimum 3-5 years in the pharmaceutical industry with specific Quality FUME experience.
• On-site presence required.

Skills

• Demonstrated understanding of cGMP regulations.
• Knowledge of Change Management and Risk Assessment methodology.
• Experience in GMP production environments.
• Experience with C&Q and Validation oversight including automation and computer systems validation.
• Familiarity with US, EU, Japan and other pharmaceutical regulations.
• Proficiency with applicable computer systems.
• Strong written and verbal communication; teamwork and interpersonal skills.
• Root cause analysis and troubleshooting skills; attention to detail; ability to maintain quality systems.
• Ability to work independently or with a team; technical writing and communication skills.
• CQE certification from ASQ and CSQA experience are preferred.
• Experience with KNEAT or other electronic validation software; start-up experience in facilities/areas; experience with GMP utilities (WFI, Clean Steam, Process Compressed Air); maintenance systems experience.

Education

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.

Additional Requirements

• Primary location is Kenosha County, Wisconsin
• Ability to travel approximately 10%
• Ability to work overtime as required