Senior Engineer, Quality Assurance - FUME

Eli Lilly and Company; Alzey; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is looking for a Senior Engineer in Quality Assurance to support its expansion in Alzey. This role is pivotal in ensuring compliance with GMP standards and enhancing quality culture within the team. The ideal candidate will have extensive experience in the pharmaceutical sector, particularly in FUME areas, and will be responsible for leading quality initiatives, mentoring staff, and ensuring inspection readiness. Join a forward-thinking organization dedicated to improving lives through innovative healthcare solutions.

Qualifikationen

• 5+ years of experience in the pharmaceutical industry with FUME quality expertise.
• Fluent in English and German, with solid GMP knowledge.

Aufgaben

• Ensure compliance with GMP standards and lead safety initiatives.
• Mentor staff on FUME quality matters and oversee maintenance activities.

Kenntnisse

FUME quality expertise

GMP compliance

Technical writing

Communication skills

Troubleshooting skills

Ausbildung

Bachelor's degree in science

Bachelor's degree in engineering

Bachelor's degree in pharmaceutical-related field

Tools

Validation software

Computer systems

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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and contribute to our communities through philanthropy and volunteerism. We dedicate our best efforts to our work and prioritize people. We seek individuals committed to making life better globally.

Position Overview:

Lilly is expanding its manufacturing footprint globally to meet patient needs and realize our future vision. We are seeking experienced quality assurance associates to support our growth in Alzey, Germany. This role offers an excellent opportunity to support new manufacturing investments and pioneering technologies.

The Senior Engineer, Quality Assurance - FUME, provides oversight, guidance, and support in Facilities, Utilities, Maintenance, and Equipment (FUME). This role is crucial for maintaining GMP compliance and ensuring inspection readiness.

Responsibilities:

1. Ensure a safe work environment, lead safety initiatives, and support all Health, Safety, and Environmental goals.
2. Lead, mentor, and coach operations and support staff on FUME quality matters.
3. Serve as a QA SME, collaborating with Global Facilities Delivery, Lilly project teams, and service providers to design facilities using QbD and QRM principles, integrating Lilly's Global Quality System requirements.
4. Review and approve facility, utility, and equipment system documents for compliance with Lilly standards and project procedures.
5. Oversee verification and qualification of systems, including review of test cases, execution, and discrepancy resolution.
6. Supervise maintenance activities, including calibrations and maintenance planning.
7. Support the development of the site quality strategy, focusing on FUME areas.
8. Build technical capabilities within the team, including mentoring new staff.
9. Promote a strong quality culture through open communication, teamwork, and employee engagement.
10. Lead initiatives supporting continuous improvement, site expansion, and quality functions.
11. Address compliance issues proactively, escalating as necessary.
12. Assist in site readiness, start-up, and ongoing quality oversight of FUME systems, including collaboration with Utilities Process Team and Computer Systems QA.

Basic Requirements:

• Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience.
• At least 5 years of experience in the pharmaceutical industry with specific FUME quality expertise.
• Fluent in English and German.
• On-site presence required.

Additional Skills/Preferences:

• Understanding of cGMP regulations.
• Experience in GMP production environments.
• Knowledge of C&Q, validation, automation, and computer systems validation.
• Familiarity with US, EU, Japan regulations.
• Proficiency with relevant computer systems.
• Strong communication, interpersonal, and troubleshooting skills.
• Attention to detail and ability to work independently or in teams.
• Technical writing skills.
• Quality Engineering Certification, CSQA, experience with electronic validation software, and facility start-up experience are preferred.
• Experience with GMP utilities and maintenance systems is advantageous.

Additional Information:

• Primary location: Alzey, Germany.
• Travel availability (~10-20%).
• Short-term assignment in a PPN manufacturing site may be required prior to role start.
• Overtime as needed.

Lilly is committed to providing accommodations for individuals with disabilities. To request assistance, please complete the workplace accommodation form. We do not discriminate based on age, race, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or other protected categories.

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