(Senior) Manager – Cleaning and Sterilization Validation TS/MS (m/f/d)

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.

Key Objectives / Deliverables:

Responsible for maintaining a safe work environment, working safely and accountable to support all HSE corporate and site goals.

Build and guide a motivated team of experts and technicians, anchored in Lilly's values, to execute initial validation and revalidation of processes such as sterilization, cleaning, filter, and shipping validation along with temperature and light mapping.

Own schedule and execution of validation activities and carry out sterilization, cleaning, filter, and shipping validation.

Develop resilient revalidation systems in close collaboration with engineering, operations, and quality partners.

Maintain validation governance on schedule, engaging stakeholders, including site leadership, to align activities with operational planning.

Mentor and develop your team to strengthen their technical maturity and capability.

Support the development of validation concepts and help harmonize your team's day-to-day practices with network standards.

Direct investigations into complex validation deviations, cleaning, sterilization, filtration, temperature mapping, and steer the extended team through product impact assessments.

Evaluate completed validation packages, consolidating and analysing data to support technical sign-off.

Manage external contracts and project resources as needed to support validation execution.

Prepare the team for health authority inspections, supporting the presentation of validation topics as needed.

Remain up to date on validation requirements, industry best practices, and network benchmarks to ensure your team's approach stays state-of-the-art.

Expected Qualifications:

BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

Understanding of GMPs and manufacturing processes

Experience building and leading a team, or strong readiness to step into a first people-leadership role

Extensive knowledge with equipment qualification and/or cleaning, and sterilization process validation

Strong knowledge of risk management and understanding / ability to use risk assessment tools as part of a validation strategy

Ability to analyse complex data and solve problems

Strong technical writing and presentation skills

Fluent in German and English

Additional Preferences:

Familiar with drug product processes and critical attributes

Experienced with H2O2 decontamination processes and validation

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.

Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.)

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.

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