MSAT Process Specialist / Expert – Formulation and Filling (m/f/d)

350 Lilly Deutschland GmbH; Alzey; On-site; EUR 53,000 - 121,000; Full time

Benefits offered by this job

Pension plan

Vacation benefits

Healthcare benefits

Flexible benefits (life insurance)

Time off and leave benefits

Well-being benefits

Job summary

Lilly Deutschland GmbH in Alzey (Rhineland-Palatinate) is seeking a qualified professional to lead formulation and aseptic filling processes. You will ensure GMP compliance, work with cross-functional teams, and support validation and lifecycle management of filling equipment and processes.

The role requires a degree in engineering or pharmacy and at least 5 years in pharma, with strong GMP knowledge and German language skills.

Qualifications

• Degree as engineer, pharmacist, or equivalent qualifying certification/training.
• At least 5 years of professional experience in the pharmaceutical industry.
• Knowledge of GMP and operational skills.
• Good knowledge of document and project management.
• German language proficiency and basic English knowledge.

Responsibilities

• Maintain a safe work environment and support GMP and site goals.
• Act as TS/MS representative for Formulation & Filling processes and address complex issues.
• Link operations with product team and local stakeholders for process topics.
• Ensure formulation and filling processes comply with industry standards and regulations.
• Provide technical guidance on formulation and aseptic filling to the site staff.
• Support validation and lifecycle management of filling processes and equipment.
• Own complex process deviations and drive change controls.
• Collaborate cross-functionally to drive improvements and assist during inspections.
• Ensure documentation is accurate, executable, and GMP-compliant.

Skills

5+ years pharma experience

GMP knowledge

German language proficiency

Basic English knowledge

Document & project management

Education

Degree in engineering, pharmacy, or equivalent training

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. 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."

Key Objectives / Deliverables

• Responsible for maintaining a safe work environment, working safely and accountable to support all HSE corporate and site goals.
• Act as TS/MS representative for the Formulation & Filling processes, addressing complex process issues in a structured manner and escalating as appropriate.
• Act as link between operations, product team and local stakeholders for process related topics.
• Ensure the preparation, formulation and filling process follow industry and authority expectation and are in full compliance with applicable regulations.
• Provide technical guidance for formulation and aseptic filling processes to the whole site and serve as a source of knowledge to the operational staff.
• Support validation and lifecycle management of filling processes, equipment, and control strategies to ensure robust and compliant commercial supply.
• Own complex process deviations and drive change controls through in-depth understanding of critical process steps and process controls.
• Collaborate cross-functionally to drive continuous improvement and present responsible area during inspections and audits.
• Ensure processes, procedures, and batch documentation are accurate, executable, and compliant with GMP and regulatory expectations.

Expected Qualifications

• Degree as engineer, pharmacist, or equivalent qualifying certification/training.
• At least 5 years of professional experience in the pharmaceutical industry.
• Knowledge of GMP and operational skills.
• Good knowledge of document and project management.
• German language proficiency and basic English knowledge.

Additional Preferences

• Experience in 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.
• Able to communicate in German.

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 €52.500 - €121.000 Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits and Perks

• 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