Supervisor Filling & LYO

Terumo Europe NV; Leverkusen; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Terumo Europe NV in Leverkusen seeks a Supervisor for aseptic filling and lyophilization operations within a sterile GMP environment. You lead on-shift teams, work hands-on in the cleanroom, and ensure safe, compliant production while driving quality and performance.

The role involves early/late shifts now and a transition to a 3-shift model including nights; development potential toward broader leadership exists.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy or Biotechnology or related field.
• Several years of experience in sterile pharmaceutical/manufacturing.
• Hands-on exposure to aseptic filling operations.
• Experience leading GMP-regulated teams is valued.
• Fluency in German and English required.

Responsabilités

• Lead aseptic filling operations on isolator-based lines for vials and pre-filled syringes.
• Plan filling campaigns, cleaning activities and lyophilization cycles.
• Oversee lyophilizer operations and post-cycle product handling.
• Maintain shift presence on the shopfloor and in the cleanroom.
• Develop and coach a multi-skilled team of operators and shift leaders.
• Act as operations owner and align activities with site KPIs.
• Monitor yield, deviations, right-first-time and efficiency; drive improvements.
• Ensure EU GMP Annex 1 compliance and contamination control.
• Lead deviation investigations and CAPA with QA, QC and Engineering.

Connaissances

People leadership

GMP knowledge

Quality-driven

Communication skills

Shift leadership

Formation

Bachelor's/Master's in Pharmacy or Biotechnology

Description du poste

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 ManufacturingAseptic Filling & Lyophilization (Filling & LYO) team is part of Terumo’s sterile drug product manufacturing operations in Leverkusen. The teamoperatesadvanced 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 an operational, in-shift leadership position. As Supervisor, you work in the shift rotation together with your team and spend a significant part of your working day on the shopfloor in the cleanroom. The team currently operates an early and late shift model and will transition to a 3-shift model, including night shifts, in the future.

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

Job summary

As a Supervisor, you lead aseptic filling and lyophilization operations within a sterile GMP environment, combiningtechnical and operational responsibilities with disciplinary people leadership. You ensure the safe, compliant and efficient execution of manufacturing activities while driving quality, performance and team development. This is a hands-on, in-shift leadership role where you work alongside your team in the cleanroom and participate in the shift rotation. The team currently works early and late shifts and will transition to a 3-shift model, including night shifts. The role is fully on-site and offers 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

Work alongside your team in the shift rotation, maintaining a strong daily presence on the shopfloor and in the cleanroom

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

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

A Bachelor’s orMaster’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 experienceleading, coaching 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 are flexible to work in a rotating shift model, including early, late and, in the future, night shifts, and enjoy combining people leadership with an active presence alongside your team in the cleanroom

Youdemonstrateownership,accountabilityand a strong commitment to quality

Transparency,integrityand 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 isrequired

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

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.