Eli Lilly

Sr. Principal Associate, Quality Engineering

Eli Lilly • $115K — $184K *
Richmond, VA 23223In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS in Engineering or a science-related field or equivalent experience.
  • Minimum of 8 years of relevant experience.
  • Experience with commissioning and qualification oversight, including automation and computer systems validation.
  • Hands-on experience with quality engineering documentation review and approval.
  • Strong understanding of cGMP and quality systems.

Responsibilities

  • Lead the Quality Engineering team, ensuring strong adherence to cGMP compliance.
  • Provide quality guidance for site facilities, utilities, and equipment throughout their life cycle.
  • Review and approve project documents to align with Global Quality Standards.
  • Mentor engineering and QA teams in quality system execution.
  • Conduct gap assessments of regulatory requirements and implement governing standards.
  • Support inspection readiness activities related to facility and equipment compliance.
  • Cultivate a quality-focused culture within the team.

Benefits

  • Comprehensive benefits program including medical, dental, and vision insurance.
  • 401(k) and pension eligibility.
  • Vacation and flexible spending accounts for healthcare and dependent care.
  • Life insurance and wellness support programs.
  • Employee assistance program and fitness benefits.
Full Job Description
Responsibilities:
  • The Sr. Principal Associate - Quality Engineering leads the Quality Engineering team, applying strong leadership, teamwork, and quality and regulatory expertise. The role provides guidance, consultation, and oversight across the design, verification, startup, and ongoing life cycle management of site facilities, utilities, and equipment. It is essential to ensuring cGMP compliance throughout the design, delivery, verification, qualification, commissioning, startup, and life cycle maintenance of site assets, utilities, and processes. The role also maintains external linkages and supports preparation for pre-approval and general inspections by regulatory agencies.


Key Objectives/Deliverables:
  • Provide cGMP and Lilly Global Quality Standard expertise working with Global Facility Delivery team, site engineering team, Lilly site staff, and selected firm to support the verification and qualification of site facilities, utilities, and equipment, employing Quality by Design (QBD) and Quality Risk Management principals and ensuring the integration of Global Quality System requirements into the design.
  • Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
  • Provide quality oversight for the verification and qualification of the parenteral building, including review of test cases, test execution, discrepancy resolution, etc.
  • Provide coaching, feedback and mentoring to engineering and QA 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.
  • Maintain and improve FUME quality systems.
  • Assist business partners in the interpretation of regulatory and corporate requirements.
  • Support the definition and execution of inspection readiness activities as it relates to facility, utilities, equipment, and maintenance.
  • Lead project initiatives needed in support of the project and Quality function.
  • Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
  • Resolve or escalate any compliance issues to the project, site, and Quality Management.


Basic Qualifications:
  • BS in Engineering or a science-related field or equivalent experience.
  • Minimum of 8 years of relevant experience required.
  • 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.


Skills:
  • Previous experience with Commissioning & Qualification (C&Q) / Verification and Validation oversight including automation and computer systems validation (CSV).
  • Experience in API/drug product manufacturing, QA or Engineering. Must have hands-on experience with quality engineering related documentation review/approval
  • Previous experience with capital project delivery.
  • Demonstrated knowledge and use of US, EU, Japan and other regulations in facilities, utilities, and equipment.
  • Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
  • 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, work under multiple priorities and tight time line.
  • Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.


Additional Information:
  • Ability to work 8 hour days -
  • Use of safety gear and adherence to site-specific safety requirements as needed
  • Travel- 0-10%

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $184,800

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

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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