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 Engineer, Quality Assurance - FUME provides oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment (FUME).  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.Leads, mentors, and coaches operations and support personnel on FUME quality matters.Acts as a QA SME, working with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Lilly Global Quality System requirements into the design and delivery of facilities, assets, and systems. Provides technical and quality review and approval of facility, utility, and equipment system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.Provides quality oversight for the verification and qualification of facility, utility, and equipment systems including review of test cases, test execution, test summaries, and discrepancy resolution. Provides QA oversight of maintenance activities including initial calibrations and maintenance plan development.Works with the site quality to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas. Supports the site organization in building technical capability, for a diverse cross-functional staff in Quality, project teams, and area process teams, including mentoring of new Quality and other project staff.Fosters a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.Leads project initiatives needed in support of site continuous improvement, site expansion, and the Quality function.Resolves or escalates any compliance issues to the project lead, site leadership, and Quality Management.Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.

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 FUME experience.Fluent in English and German.On-site presence required.

Additional Skills/Preferences:

Demonstrated understanding of cGMP regulations.Previous experience in GMP production environments.Previous experience with C&Q and Validation oversight including automation and computer systems validationDemonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturingProficiency with applicable computer systemsDemonstrated strong oral and written communication skillsDemonstrated interpersonal skills and the ability to work as a teamRoot cause analysis/troubleshooting skillsDemonstrated attention to detail and ability to maintain quality systemsProven ability to work independently or as part of a Team to resolve an issueTechnical Writing and Communication SkillsQuality Engineering CertificationComputer System Quality Assurance (CSQA) experiencePrevious use of KNEAT – or other electronic validation softwarePrevious facility or area start up experience.Previous experience with GMP utilities including WFI, Clean Steam, Process Compressed Air.Previous experience with Maintenance systems.

Additional Information:

Primary location is Alzey, GermanyAbility to travel (approximately 10-20 %)Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the roleAbility 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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