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

350 Lilly Deutschland GmbH; Alzey; On-site; EUR 95,000 - 125,000; Full time

Benefits offered by this job

Pension plan

Vacation benefits

Healthcare benefits

Flexible benefits

Job summary

Lilly Deutschland GmbH in Alzey is seeking a senior validation lead to guide a team through initial validation and revalidation of processes like sterilization, cleaning, and filtration. You will own scheduling, governances, and collaborate with engineering, operations, and quality partners to ensure alignment with site goals.

You will mentor the team, develop validation concepts, and respond to health authority inspections, while staying current on industry benchmarks and network standards.

Qualifications

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related field.
• Understanding of GMPs and manufacturing processes.
• Experience building and leading a team or readiness for first leadership role.
• Extensive knowledge with equipment qualification, cleaning, and sterilization validation.
• Strong risk management knowledge and use of risk assessment tools.
• Ability to analyze complex data and solve problems.
• Strong technical writing and presentation skills.
• Fluent in German and English.

Responsibilities

• Maintain a safe work environment and support HSE goals.
• Build and guide a team to execute validation of processes (sterilization, cleaning, filtration, shipping).
• Own schedule and execution of validation activities.
• Develop resilient revalidation systems with engineering, operations, and quality partners.
• Maintain governance on schedule and align with operational planning.
• Mentor and develop the team to raise technical maturity.
• Support development of validation concepts and harmonize practices with network standards.
• Lead investigations into complex validation deviations and assess product impact.
• Evaluate validation packages and support technical sign-off.
• Manage external contracts and resources for validation execution.
• Prepare for health authority inspections and present validation topics as needed.
• Stay up to date on validation requirements and network benchmarks.

Skills

Team leadership

GMP knowledge

Data analysis

Technical writing

German & English

Education

BS or MS in Microbiology/Biochemistry/Engineering

Job description

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.

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

• 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
• 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 At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly