Senior Quality Scientist, Device Assembly and Packaging (m/w/d)

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 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 put people first.

At Lilly in Germany, we are planning and building a high-tech production facility in Alzey (Rhineland-Palatinate) to expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the Lilly values of Excellence, Integrity, and Respect for People.

Position

Senior Quality Scientist, Device Assembly and Packaging (m/w/d)

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. This is an outstanding opportunity to support new manufacturing investments and pioneering technologies.

Responsibilities

• The Senior Quality Scientist, DAP provides daily oversight, assistance, and guidance to the site-based process team supporting device assembly or packaging manufacturing areas.

• Acts as the QA representative supporting the process team; provides guidance on non-conformance investigations, change controls, procedures, validations, batch disposition, commissioning and qualification activities.

• Advises and supports other floor QA Representatives to maintain GMP compliance and inspection readiness.

• Ensures regular presence in operational areas to monitor GMP programs and quality systems.

• Participates in self-led inspections and supports regulatory inspections.

• Initiates, reviews, and approves documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation documents, change controls, engineering documents).

• Participates in continuous improvement projects to improve productivity within the local process team or quality organization.

• Approves commissioning, qualification, and validation documents for computer systems and equipment to ensure compliance with quality standards.

• Networks with Global Parenteral Network sites to benchmark and replicate best practices.

Qualifications

Basic Requirements:

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

• Minimum 5 years in the pharmaceutical industry with QA experience overseeing shop-floor execution.

• Demonstrated understanding of cGMP regulations, good documentation practices, data integrity, and regulatory compliance.

• Fluent in English and German.

• On-site presence required.

Additional Requirements:

• Experience in pharmaceutical manufacturing environments.

• Experience with commissioning and qualification and validation, including automation and computer systems validation.

• Knowledge of US, EU, Japan, and other regulations in pharmaceutical manufacturing.

• Proficiency with applicable computer systems.

• Strong oral and written communication skills and the ability to work as a team.

• Root cause analysis and troubleshooting skills.

• Attention to detail and ability to maintain quality systems.

• Ability to work independently or as part of a team to resolve issues.

• Technical writing and communication skills; CSQA experience; experience with Manufacturing Execution Systems; experience with KNEAT or other electronic validation software.

Benefits and Development

• Pioneering spirit: part of a team that will grow to up to 1,000 colleagues over the next three years.

• Innovation: work in a high-tech medical production facility with advanced technology.

• Creative freedom: opportunity to contribute ideas and implement them in cross-functional teams.

• Development: opportunities for professional development through Corporate Lilly University.

• Financial benefits: competitive salary with a company pension plan and other benefits.

Note: If you require accommodation to submit a resume, please complete the accommodation request form (careers.lilly.com/us/en/workplace-accommodation) for assistance. Lilly is an equal opportunity employer and 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. We look forward to your application.

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