Eli Lilly and Company
Position Title: Associate Director - Quality Engineer
Job Type:
Full-time
Location:
Lilly-Richmond, Virginia
Job Function:
Quality
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 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.
Key Responsibilities
Provide direct quality oversight of production, engineering, automation, and laboratory operations.
Review and approve documents including 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.
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 communication skills.
Strong attention to detail.
Proficiency with computer system applications.
Knowledge of cGMPs and quality systems.
Understanding of statistical tools and analysis.
Excellent interpersonal 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.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600.
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 such as 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.
Equal Employment Opportunity 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.
#WeAreLilly
#J-18808-Ljbffr
Full-time
Location:
Lilly-Richmond, Virginia
Job Function:
Quality
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 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.
Key Responsibilities
Provide direct quality oversight of production, engineering, automation, and laboratory operations.
Review and approve documents including 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.
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 communication skills.
Strong attention to detail.
Proficiency with computer system applications.
Knowledge of cGMPs and quality systems.
Understanding of statistical tools and analysis.
Excellent interpersonal 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.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600.
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 such as 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.
Equal Employment Opportunity 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.
#WeAreLilly
#J-18808-Ljbffr