Senior/Principal Scientist Validation

350 Lilly Deutschland GmbH; Alzey; Vor Ort; EUR 53.000 - 110.000; Vollzeit

Benefits dieser Stelle

Pension plan

Vacation benefits

Healthcare benefits

Flexible benefits

Life insurance

Time off

Well-being programs

Zusammenfassung

Lilly Deutschland GmbH in Germany is seeking a Senior Principal Scientist Validation (m/w/d) to lead validation of production equipment and systems at a new high-tech parenteral site in Alzey. You will prepare and review validation protocols, support change controls, regulatory submissions, and ensure GMP compliance.

Required: engineering degree or pharmacy qualification with at least 5 years in industry, German and basic English, and strong analytical, communication and teamwork skills.

Qualifikationen

• Engineer, pharmacist, or equivalent with at least 5 years in the industry.
• GMP operation skills and document management knowledge.
• German language with basic English proficiency.

Aufgaben

• Sterilization validation.
• Cleaning validation.
• Filter validation.
• Shipping validation.
• Process validation.
• Other TS/MS related activities.

Kenntnisse

Parenteral manufacturing

Analytical skills

Interpersonal/communication

Independent / team worker

Team coordination without direct power

Ausbildung

Engineer or equivalent

Pharmacist

Jobbeschreibung

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 TSMS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TSMS 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.

Senior Principal Scientist Validation (m/w/d)

As Principal Scientist Validation, you will be expected to instruct and support the validation of production equipment and systems.

• Sterilization validation
• Cleaning validation
• Filter validation
• Shipping validation
• Process validation
• Other TS/MS related activity

Prepare, review relevant technical documents, as required, such as:

• Change controls
• Regulatory submissions
• Deviation investigations
• Validation protocols and summary reports
• Processing records
• Procedures

Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.

Initiate related validation protocols and reports, and coordinate validation related activities.

Complete required and assigned trainings on-time.

Key Objectives / Deliverables

Instruct and support validation of production equipment and systems. Prepare, review and support relevant technical documents. Execute validation related activities. Ensure compliance with the final objective and coordinate with local project team.

Requirements

Degree/qualifying certifications/training/experience: Engineer, pharmacist, or equivalent with professional experience (at least 5 years) in the industry. Knowledge of GMP Operation skills. Good knowledge of document and project management. You have German and basic English knowledge.

Additional Skills / Preferences

• Parenteral manufacturing
• Strong analytical and synthesis skills
• Excellent interpersonal and communication skills
• Ability to work independently and in a team
• Ability to coordinate teams without direct hierarchical power

What can you look forward to with us?

At Lilly, we believe in creating an environment where innovation thrives and every team member can shine. Pioneering Spirit: Be part of a groundbreaking team of specialized professionals that will grow to up to 1,000 colleagues over the next three years. You'll be at the forefront of pharmaceutical innovation, contributing to life-changing advancements.

Cutting-Edge Technology: Work in a state-of-the-art medical high-tech production facility equipped with the latest and most advanced technology. You'll have the tools and resources to excel in your role and push the boundaries of what's possible.

Creative Freedom: From day one, you'll have the freedom to bring your ideas to life and make a real impact. Collaborate with cross-functional teams and see your innovative solutions implemented in a dynamic and supportive environment.

Personal and Professional Growth: We are committed to your development. Through our "Corporate Lilly University," you'll have access to a wealth of professional development opportunities, ensuring you can grow and advance your career on a global scale.

At Lilly we’re committed to inclusion and equal opportunity.

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 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is €52,500 - €110,000. Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• 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.

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.

We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!