Senior Device Assembly and Packaging Expert - MSAT (m/f/d)

TS/MS Device Assembly & Packaging Lead

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.

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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will 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, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of 'Excellence,' 'Integrity,' and 'Respect for People.'

In this role you will be part of the TS/MS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TS/MS team is the technical owner of the process - from tech transfer and validation through commercial lifecycle management. Our decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site runs for the next decades, with direct visibility to site leadership and Lilly's global technical network.

Key Objectives / Deliverables:

• Ensure a safe working environment by adhering to safe practices while supporting corporate and site HSE objectives

• Own the Alzey device assembly, printed packaging materials and serialization processes, from implementation during start-up to routine commercial operation.

• Lead the TS/MS device assembly and packaging team technically, and mentor scientists and engineers across disciplines.

• Act as the TS/MS escalation point for the operations teams, guiding troubleshooting and supporting batch decisions.

• Lead risk management (e.g. PFMEA) and technical investigations into deviations and complaints, and drive root cause analysis and process improvements.

• Author, review and approve technical documentation. This includes process flow diagrams, PFMEAs, specifications, validation documents, procedures, change controls, deviations, annual product reviews and regulatory submissions.

• Define statistical metrics (e.g. SPC, process capability) to monitor process performance, and lead technical projects that improve process control and productivity.

• Represent site TS/MS with component and packaging suppliers and with Lilly's global device and parenteral networks, and support audits and inspections.

• contribute to the stability strategy and contamination control strategy for Alzey products

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Expected Qualifications:

• A bachelor's or master's degree in engineering (e.g. mechanical, process, packaging, biomedical) or a related scientific discipline.

• 8+ years of experience with device assembly and/or packaging processes in a GMP-regulated environment.

• Hands-on experience leading root cause investigations.

• The ability to analyze complex data and solve problems with a scientific, risk-based approach.

• A track record of working effectively in cross-functional teams.

• Fluent English.

Additional Preference:

• Serialization experience

• Experience with greenfield projects, site start-ups or new process introduction.

• Experience leading or mentoring others.

• German language skills.

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What to consider:

• Role is Monday through Friday site-based (Alzey) with the ability to travel to Indianapolis and other global Lilly sites as required.

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

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.