At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Organization Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. #WeAreLilly
Position Brand Description:
The Engineer – FUME is responsible for providing technical guidance and leadership to the Richmond, Virginia API/Fill finish Operations and Richmond Facilities Management sites regarding the quality standards employed to maintain and improve site operations. The area of focus is utilities, including bulk distributed materials (BDMs), but will require backup in facilities, systems and equipment management.
Key Objectives/Deliverables:
- Provide direct quality oversight of production, engineering, automation, and laboratory operations.
- Review and approve documents including, but not limited to, procedures, change control proposals, deviations, equipment/system qualification/validation, analytical methods, and computerized system validations as business FUME.
- Provide quality guidance and recommendations regarding manufacturing, materials, utilities, maintenance, and laboratory issues.
- Participate in aberrant data investigations (i.e., deviation investigations).
- Conduct analytical data review including stability data.
- Disposition API Intermediates and raw materials, as appropriate.
- Provide coaching, feedback and mentoring to engineering and FUME as it relates to execution of quality systems.
- Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.
- Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), Asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate.
- Conduct gap assessments of global requirements and ensure implementation of the governing standards.
- Participate in and/or lead, support self-inspection activities and regulatory inspections.
- Maintain and improve FUME quality systems.
- Assist business partners in the interpretation of regulatory and corporate requirements.
Basic Requirements:
- BS in Engineering or a science-related field or equivalent experience.
Must have hands-on experience with ADC (Antibody Drug Conjugate) processes.
Minimum of 8 years of relevant experience in engineering or quality roles.
Additional Preferences:
- Experience in API or finished product manufacturing, FUME or Engineering
- Experience with system and equipment qualifications
- Demonstrated strong written and verbal communications skills.
- Strong attention to detail.
- Proficiency with computer system applications.
- Knowledge of cGMPs and quality systems.
- Understanding of statistical tools and analysis.
- Excellent interpersonal skills and networking skills.
- Ability to organize and prioritize multiple tasks.
- Previous experience in FUME, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.
Education Requirements:
- BS in Engineering or science-related field or equivalent experience.
Other Information:
- No certifications required.
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
- Must support 24 hour/day operations.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
