Microbiologist (m/w/d)

Eli Lilly and Company; Alzey; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Benefits dieser Stelle

Excellent company pension plan

Attractive salary

Individual benefits

Career development opportunities

Zusammenfassung

A global healthcare leader in Alzey is seeking a motivated candidate for conducting microbiological testing and ensuring compliance with regulations. The role requires an A.S. with 2+ years or a B.S./M.S. in a related science. Ideal candidates are detail-oriented, team players who can work independently. Join a pioneering team committed to making life better for people worldwide, backed by excellent career development and benefits.

Qualifikationen

• A.S. with 2+ years industry experience in a related science.
• B.S. or M.S. with 0+ years industry experience in a related science.
• Great attention to detail and teamwork skills.

Aufgaben

• Ensure timely completion of work to support batch release.
• Adhere to EHS requirements and maintain cleanliness.
• Perform microbiological testing and data review.
• Execute activities in compliance with SOPs.
• Participate in cross-functional teams as needed.

Kenntnisse

Excellent teamwork and communication skills

Attention to detail

Ability to work independently

Competence in Microsoft Office

Knowledge of cGMP regulations

Ausbildung

A.S. in a related science

B.S. or M.S. in a related science

Tools

LIMS

Microsoft Office

MODA

SmartLab

TrackWise

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.

Overview

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."

Responsibilities

• Timeliness: Ensure work is completed in a timely manner to support batch release and site priorities.
• Safety and GMP Compliance: Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures. Maintain cleanliness and contamination control, in alignment with cGMPs, chemical hygiene, and biosafety guidelines.
• Compliance and Documentation: Execute activities in compliance with applicable standard operating procedures (SOPs), methods/protocols, good documentation practices (GDP), and regulatory guidelines.
• Data Recording and Data Integrity: Execute activities in accordance with data integrity standards and ALCOA+ principles.
• Data Review: Perform data review, as assigned, to ensure accuracy and compliance.
• Deviation Identification and Investigation: Identify and escalate any atypical results and potential deviations. Participate in root cause analysis for laboratory investigations and implement corrective/preventive actions, as required. Provide data to support manufacturing investigations, as required.
• Continuous Improvement: Identify and communicate opportunities for improvement.
• Cross-functional Participation: Participate in cross-functional teams (e.g., process team, global working teams, etc.), as required.
• Training and Mentorship: Maintain training competencies and only execute work where qualified. Participate in training and mentorship, as requested.
• Audit and Inspection Support: Execute activities in a compliant manner that supports an ongoing state of inspection readiness. Participate in pre-inspection reviews/checks and provide on-site support during audit/inspections, as requested.

What tasks await you?

• Perform routine microbiological testing on water, gas, in-process materials, final products, raw materials, environmental/water samples, finished goods
• Performs material qualifications and QC inventory control.
• Performs identification of organisms.
• Performs Bioburden, Endotoxin, Sterility, Microbial Identification, and biological indicator testing.
• Prepares and maintains microbial stock culture.
• Performs method suitability (bacteriostasis/fungi stasis) testing.
• Assists in special projects (i.e. validations, microbiological studies, etc.).
• Creates, revises, or reviews documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, or invalid assays).
• Performs analytical and deviations investigations
• Reviews microbiology testing data and logbooks
• Train other analysts on procedures, as needed.
• Ensuring that laboratory equipment is maintained and within calibration

How do you convince us?

• A.S with 2+ years industry experience in a related science such as Biology, Biochemistry or other science discipline
• B.S or M.S with 0 + years industry experience in a related science such as Biology, Biochemistry or other science discipline.
• Excellent teamwork and communication skills.
• Great attention to detail.
• Ability to work independently and achieve problem resolution with minimal supervision.
• Competent in use of Microsoft Office programs. Flexibility to work weekends, overtime, and holidays as needed.
• Comfortable with computerized data storage systems (i.e. MODA, LIMS, SmartLab, TrackWise, etc).
• Good working knowledge of cGMP regulations.

Additional Information

• Primary location is Alzey
• On-site presence required

What can you look forward to with us?

• Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
• Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology.
• Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams.
• Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our "Corporate Lilly University."
• Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.

Have we piqued your interest? Then please apply online with your complete application documents through our applicant portal.

We look forward to your application!

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.

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