Regulatory Affairs à Allemagne

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, 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 Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Technician, Quality Control - Environmental Monitoring, performs routine and investigational environmental monitoring of classified manufacturing, filling, and support areas. The technician provides daily support to EM laboratory operations including sample incubation, reading, and verification. This position is essential for maintaining GMP compliance and ensuring inspection readiness.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Supports production operations by means of EM sampling of classified manufacturing, filling, and support areas (e.g., utilities) and operations personnel.
• Supports daily EM laboratory operations including sample incubation, reading, and verification.
• Supports process/equipment qualification activities, as necessary.
• Ensures compliance with current Good Manufacturing Practices (cGMPs) and maintains constant inspection-readiness.
• Ensures that data-integrity is maintained.
• Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.

Basic Requirements:

• High school diploma or equivalent
• Minimum 3 years in the pharmaceutical industry with specific environmental monitoring experience.
• On-site presence required.

Additional Skills/Preferences:

• Fluent in English and German.
• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Proficiency with applicable computer systems.
• Strong documentation skills and attention to detail.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Technical Writing and Communication Skills.
• Previous regulatory inspection readiness and inspection execution experience.
• Previous Environmental Monitoring experience.
• Previous experience supporting Aseptic manufacturing or production (traditional clean room, Restricted Access Barrier Systems, Isolators).
• Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
• Understanding of compliance requirements and regulatory expectations for lab systems including EM.

Additional Information:

• Primary location is Alzey, Germany.
• Ability to travel (approximately 10%).
• Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role.
• Ability to work 12-hour shifts to support production operations; hiring for multiple shifts.
• Must be able to stand/walk for extended periods of time.
• Ability to work overtime 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.

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.

#WeAreLilly