Senior Scientist, Quality Control - Equipment

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 Senior Scientist, Quality Control – Equipment, is responsible for asset delivery and maintenance in the Quality Control Laboratory. This role requires an understanding of corporate quality systems, a detail-oriented quality mindset with an understanding of analytical/microbiology laboratory equipment, knowledge of lab methods to understand intended use of equipment and their failure modes and effects. The individual in this position must possess skills which include equipment troubleshooting, prioritization, written and oral communication, decision making, strong interpersonal/people management, computer applications, and problem-solving.

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.
• Authors equipment qualification/validation protocols and strategies for the QC Laboratories.
• Provides support for equipment relocation and qualification associated with Lab master plans.
• Participates in data integrity by design, mitigation through controls and improvement initiatives.
• Executes technical review and execution of qualification/validation protocols.
• Recommends and specifies equipment purchases based on user requirements.
• Communicates with other functions and external vendors regarding qualification issues and key operational objectives.
• Acts as liaison between the maintenance team and laboratory personnel to schedule preventative and corrective maintenance of equipment.
• Applies knowledge of quality principles, cGMPs, regulations, corporate standards, practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
• Interacts effectively with customers, support groups and development.
• Networks with other areas to understand best practices and share knowledge to ensure customer needs are met.
• Identifies improvements and streamlines quality systems relating to equipment.
• Serves as equipment subject matter expert in the review of technical documents.
• Acts as subject matter expert and originator of change controls.
• Originates and investigates deviations in the QC laboratory.
• Multitasks, prioritizes, and coordinates work to meet customer’s needs.
• Demonstrates problem solving and investigative skills.
• Makes decisions based on knowledge, experience, best practices and requirements.
• Works independently and accurately with minimal supervision.
  

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific Quality Control and laboratory computer system experience.
• On-site presence required.

Additional Skills/Preferences:

• Fluent in English and German.
• Demonstrated understanding of cGMP regulations.
• Experience supporting laboratory equipment in a GMP environment.
• Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
• Understanding of compliance requirements and regulatory expectations for laboratory systems.
• Previous experience with managing data integrity regulations and controls.
• Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva.
• Deep understanding of compliance requirements and regulatory expectations
• Demonstrated accuracy and proficiency in analytical skills.
• Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
• Excellent written and oral communication skills
• Previous LEAN experience: ability to drive continuous improvement.
• Strong technical aptitude and ability to train and mentor others.
• Project management experience.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills
• Understanding of statistical tools and analyses.
• 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.
• Previous regulatory inspection readiness and inspection execution experience.

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 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.

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