Quality specialist Jobs in Monheim Am Rhein

Supervisor Aseptic Filling & Lyophilization (Filling & LYO)

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for.

Department information

Our Manufacturing Aseptic Filling & Lyophilization (Filling & LYO) team is part of Terumo’s sterile drug product manufacturing operations in Leverkusen. The team operates advanced aseptic filling lines and lyophilization (freeze-drying) processes within a controlled cleanroom environment, producing sterile pharmaceutical products to the highest GMP standards.

The team currently consists of around 15-16 employees supporting both existing and newly implemented production lines. As the site continues to expand, additional leadership capacity is required to support increasing operational complexity and ensure sustainable growth.

This is a highly collaborative and quality-driven environment where production, technical teams and support functions work closely together.

Job summary

As a supervisor, you lead aseptic filling and lyophilization operations within a sterile GMP environment, combining hands-on production oversight with team leadership. You ensure safe, compliant and efficient execution of manufacturing activities while driving quality, performance and team development. This is a fully on-site, shift-based role within a growing operation, offering development potential towards broader leadership responsibilities.

Job responsibilities

• Lead and coordinate daily aseptic filling operations on isolator-based production lines for vial and pre-filled syringe products
• Plan and execute filling campaigns, cleaning activities and lyophilization cycles in line with production schedules
• Oversee lyophilizer operations, including loading activities, cycle execution and post-cycle product handling
• You manage and develop a multi-skilled team of operators and shift leaders while fostering engagement, accountability and performance
• Act as the operational owner of the area, aligning production activities with business objectives and site KPIs
• Monitor performance across key metrics such as yield, deviations, right-first-time and operational efficiency, and initiate improvement actions where needed
• You ensure full compliance with EU GMP Annex 1 requirements, contamination control strategies and sterile manufacturing standards
• Lead deviation investigations, CAPA activities and environmental monitoring follow-up actions while maintaining inspection readiness and collaborating closely with QA, QC and Engineering teams

Profile description

• A Bachelor’s or Master’s degree in Pharmacy, Biotechnology or another relevant scientific discipline provides an excellent basis for this role
• Several years of experience within a sterile pharmaceutical or biopharmaceutical manufacturing environment are essential
• Hands-on exposure to aseptic filling operations and sterile manufacturing processes is a key requirement
• Previous experience leading or coordinating teams within a GMP-regulated environment is highly valued
• A solid understanding of EU GMP Annex 1, contamination control principles and aseptic manufacturing practices is important
• Experience with batch documentation, deviations and CAPA processes will allow you to contribute quickly
• You demonstrate ownership, accountability and a strong commitment to quality
• Transparency, integrity and collaboration characterize the way you work and interact with others
• Strong communication skills enable you to build effective relationships across functions and levels within the organization
• Fluency in German and English is required

Offer

You will work in a high-tech sterile manufacturing environment where quality and compliance are key. You will have the opportunity to play a critical role in managing complex production processes and developing your team within a highly regulated GMP setting.

Contact person

Marjolein Buyl and Tristan Segers, Talent Acquisition

Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.