Site Sterility Steward

Eli Lilly and Company; Alzey; Vor Ort; EUR 110.000 - 140.000; Vollzeit

Zusammenfassung

Lilly in Germany is building a high‑tech parenteral production site in Alzey and seeks a seasoned sterility assurance expert to join the TSMS team. You will guide processes from tech transfer to lifecycle management, influencing control strategies and program robustness for the site over the coming decades, with visibility to site leadership and Lilly's global network.

You will lead complex sterility programs, develop monitoring strategies, and mentor scientists while collaborating across

Qualifikationen

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related field.
• In depth knowledge of GMPs and internal standards.
• In depth knowledge of parenteral processing.
• In depth knowledge of microbiology and sterility assurance.
• In depth knowledge of risk management and risk assessment tools.
• Strong analytical and problem-solving abilities.
• Technical writing and presentation skills.
• Teamwork and interpersonal influence.

Aufgaben

• Maintain a safe work environment and support all HSE goals.
• Understand principles required for manufacturing parenteral drug products.
• Use sterility assurance risk management for process controls to prevent contamination.
• Lead or participate in sterility assurance projects.
• Develop and execute monitoring strategies focusing on microbial risk.
• Lead deviations for root cause analysis in sterility programs.
• Stay updated on external regulatory requirements for sterility programs.
• Contribute to improvements and revisions of corporate sterility guidance.
• Provide design input for new processes and facilities at Alzey.
• Represent sterility programs during audits and regulatory inspections.
• Assist with regulatory submissions for sterility programs.
• Create and deliver sterility training for hires and partners.
• Mentor less senior scientists and cross-functional staff.
• Provide cross-site consultation within the Parenteral Network.

Kenntnisse

GMP knowledge

Parenteral processing

Microbiology

Risk assessment

Data analysis

Technical writing

Presentation skills

Teamwork

Ausbildung

BS in Microbiology or related

MS in Microbiology or related

Jobbeschreibung

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.

Position Description:

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.

Key Objectives / Deliverables:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
• Lead and / or participate in complex projects associated with sterility assurance programs.
• Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
• Lead major deviations for root cause analysis related to sterility assurance programs.
• Remain abreast of external regulatory requirements associated with sterility assurance programs.
• Influence revision to corporate guidance associated with sterility assurance programs.
• Identify and implement continuous improvement for sterility assurance programs.
• Provide design input related to new processes (e.g., facilities, equipment, etc.) for Alzey.
• Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections.
• Assists with writing of regulatory submissions for sterility assurance programs.
• Create, review, approve and provide sterility assurance training for new hires and personnel from other sites.
• Provide technical mentorship to a less senior scientists within the TS/MS organization.
• Provide technical mentorship to a less senior cross-functional personnel within Alzey.
• Provide technical consultation across the Parenteral Network.

Minimum Requirements:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• In depth knowledge and understanding of GMPs and internal standards
• In depth knowledge of parenteral processing
• In depth knowledge of microbiology and sterility assurance
• In depth knowledge of risk management and the understanding / ability to use risk assessment tools
• Ability to analyze complex data and solve problems
• Strong technical writing and presentation skills
• Teamwork / interpersonal skills ability to effectively influence

Additional Preferences:

• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
• Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)

Education Requirements:

• Minimum 7 years’ experience in the biopharmaceutical industry
• Advanced Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred
• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

Other Information:

• Please apply with Resumé in English
• Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
• Position will be based out of Alzey site with 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.

Lillydoes 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.

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