Senior/Sr. Principal Engineer, Quality Assurance

Responsibilities

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.
• Serve as the site subject matter expert for Facility, Utility, Maintenance, and Equipment (FUME) Quality Systems and asset lifecycle compliance.
• Provide strategic technical leadership for qualification, verification and maintenance of GMP assets.
• 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 manufacturing facilities, utilities, equipment and supporting systems.
• Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems.
• Maintain and improve 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.
• 8+ years in pharmaceutical quality/engineering with significant FUME quality systems experience and experience supporting API and/or OSD manufacturing operations.
• Candidates must have current authorisation to work in the European Union.

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, Oral Solid Dosage (OSD), QA or Engineering. Must have hands-on experience with quality engineering related documentation review/approval.
• Previous experience with capital project delivery.
• 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.
• Experience with Instrument Qualification activities would be advantageous.

On-site Requirement

• This is 100% full-time on-site role.

Travel Requirements

• We typically expect travel to be 10-20% during the design and delivery phase for engineering meetings, training, and job shadowing opportunities.

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

€60,000 - €99,000

Full-time equivalent employees may also 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 pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) 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.

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