Supervisor Filling & LYO

Terumo Europe; Leverkusen; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Terumo Europe is seeking a seasoned manufacturing leader to oversee aseptic filling operations on isolator-based lines for vial and pre-filled syringe products. You will plan campaigns, manage lyophilization cycles, and lead a multi-skilled team, driving performance and quality in a GMP environment.

The role requires a deep understanding of EU GMP Annex 1, CAPA and environmental monitoring, plus hands-on experience in sterile manufacturing.

Qualifikationen

• Bachelor's or Master's degree in Pharmacy, Biotechnology or related scientific discipline.
• Several years of experience in sterile pharmaceutical or biopharmaceutical manufacturing.
• Hands-on exposure to aseptic filling operations and sterile manufacturing processes.
• Experience leading or coordinating teams within a GMP-regulated environment.
• Solid understanding of EU GMP Annex 1 and contamination control principles.
• Experience with batch documentation, deviations and CAPA processes.
• Demonstrates ownership, accountability and commitment to quality.
• Fluency in German and English.

Aufgaben

• 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.
• Manage and develop a multi-skilled team of operators and shift leaders while fostering engagement and performance.
• Act as the operational owner of the area, aligning production activities with business objectives and site KPIs.
• Monitor performance across yield, deviations, right-first-time and efficiency; initiate improvements.
• Ensure compliance with EU GMP Annex 1 requirements and sterile manufacturing standards.
• Lead deviation investigations, CAPA activities and environmental monitoring follow-up with QA/QC/Engineering.
• Collaborate with QA, QC and Engineering to maintain inspection readiness.
• Demonstrate strong communication across functions and levels within the organization.

Kenntnisse

Leadership

GMP knowledge

Aseptic filling

CAPA experience

Environmental monitoring

Batch documentation

Contamination control

Communication skills

Team coordination

Problem solving

Ausbildung

Bachelor's or Master's degree in Pharmacy or Biotechnology

Jobbeschreibung

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.

• 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
• 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
  

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.