Senior FUME Quality & Compliance Engineer

Eli Lilly and Company; Katwijk; On-site; EUR 60,000 - 99,000; Full time

Benefits offered by this job

Company bonus

Pension plan

Healthcare benefits

Flexible benefits

Time off and leave benefits

Well-being programs

Job summary

Eli Lilly and Company in Katwijk is hiring for a 100% on-site role focused on quality and engineering for site facilities and equipment. The job emphasizes cGMP compliance, verification, and lifecycle management of assets within a state-of-the-art facility in the Netherlands.

The role requires extensive experience in API/OSD manufacturing, strong documentation review skills, and collaboration across global quality and engineering teams. A 12-month contract with a view to permanence is offered.

Qualifications

• BS in Engineering or a science-related field or equivalent experience.
• 8+ years in pharmaceutical quality/engineering with FUME quality systems experience.
• Current authorisation to work in the European Union.

Responsibilities

• Provide cGMP and Lilly Global Quality Standard expertise for verification and qualification of site facilities, utilities, and equipment.
• Act as site SME for Facility, Utility, Maintenance and Equipment (FUME) quality systems.
• Lead qualification, verification and maintenance of GMP assets and related documentation.
• Provide quality oversight for validation of manufacturing facilities, utilities and equipment.
• Coach and mentor engineering and QA teams on quality systems and processes.

Skills

C&Q oversight

API/OSD experience

Capital projects

Cross-functional communication

Attention to detail

CSV familiarity

Quality systems knowledge

Statistics & analysis

Documentation review

Education

BS in Engineering or science

Tools

Automation

GxP/computer systems

Regulatory compliance tools

Job description

Eli Lilly and Company in Katwijk is hiring for a 100% on-site role focused on quality and engineering for site facilities and equipment. The job emphasizes cGMP compliance, verification, and lifecycle management of assets within a state-of-the-art facility in the Netherlands.

The role requires extensive experience in API/OSD manufacturing, strong documentation review skills, and collaboration across global quality and engineering teams. A 12-month contract with a view to permanence is offered.