Senior Quality Engineer

Datwyler Group; Alken; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Datwyler Healthcare seeks a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to lead global microbiology quality strategies across our manufacturing network. You will drive sterility assurance programs, contamination control, and testing strategies while partnering with Quality, R&D, Manufacturing, Regulatory Affairs, and Operations.

The role requires a Master’s or PhD in a related field, 10+ years of relevant experience, expertise in GMP compliance, and excellent

Qualifications

• Master's or PhD in a relevant scientific discipline with advanced microbiology expertise.
• Minimum 10 years of experience in pharma/biotech/medical device packaging.
• Strong expertise in sterile manufacturing, sterility assurance, contamination control, and process validation.
• Solid understanding of GMP requirements, including EU GMP Annex 1 and Quality Risk Management.
• Proven ability to provide scientific leadership across a global organization.
• Excellent communication and collaboration skills.
• Fluent in English.

Responsabilités

• Lead and continuously improve the global Contamination Control Strategy in line with EU GMP Annex 1.
• Drive microbiological risk assessments and define contamination prevention measures.
• Provide technical leadership on microbiological testing, including bioburden, endotoxin, and sterility-related methods.
• Define and oversee environmental monitoring and cleanroom control strategies across manufacturing sites.
• Develop and maintain global sterility assurance approaches for pharmaceutical primary packaging components.
• Support validation of sterilization, cleaning, washing, and packaging processes.
• Lead complex microbiological investigations, root cause analyses, and CAPA activities.
• Partner with cross-functional teams to drive quality improvements and ensure regulatory compliance.

Connaissances

Fluent English

Communication skills

Collaboration skills

Leadership

Formation

Master's degree or PhD in Microbiology, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering, or related field

Description du poste

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Senior Quality Engineer – Microbiology, Sterility & Contamination Control

Shape the Future of Quality and Patient Safety in Healthcare

To strengthen our global Quality organization, we are looking for a Senior Quality Engineer – Microbiology, Sterility & Contamination Control. In this highly visible role, you will serve as the global Subject Matter Expert (SME), driving microbiological quality, sterility assurance, and contamination control strategies across our global manufacturing network.

This is a unique opportunity to influence product quality, regulatory compliance, and patient safety on a global scale.

Your Role

As our global expert in microbiology and contamination control, you will lead the development and continuous improvement of microbiological testing strategies, sterility assurance programs, and contamination control systems across products, manufacturing processes, sterilization technologies, and supply chain activities.

Working closely with Quality, R&D, Manufacturing, Engineering, Regulatory Affairs, and Operations teams, you will help define best practices and ensure compliance with international regulatory requirements.

Key Responsibilities

• Lead and continuously improve Datwyler Healthcare's global Contamination Control Strategy (CCS) in line with EU GMP Annex 1 requirements
• Drive microbiological risk assessments and define effective contamination prevention measures
• Provide technical leadership on microbiological testing, including bioburden, endotoxin, and sterility-related methods
• Define and oversee environmental monitoring and cleanroom control strategies across manufacturing sites
• Develop and maintain global sterility assurance approaches for pharmaceutical primary packaging components
• Support validation of sterilization, cleaning, washing, and packaging processes
• Lead complex microbiological investigations, root cause analyses, and CAPA activities
• Partner with cross-functional teams to drive quality improvements and ensure regulatory compliance

What You Bring

• Master's degree or PhD in Microbiology, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering, or a related scientific discipline
• Minimum 10 years of experience in the pharmaceutical, biotechnology, medical device, or primary packaging industry
• Strong expertise in sterile manufacturing, sterility assurance, contamination control, and process validation
• Solid understanding of GMP requirements, including EU GMP Annex 1 and Quality Risk Management principles
• Proven ability to provide scientific leadership and influence stakeholders across a global organization
• Excellent communication and collaboration skills
• Fluent in English

Why Join Datwyler Healthcare?

• Make a direct impact on patient safety and product quality worldwide
• Take ownership of a global expert role with significant visibility and influence
• Work in an innovative and highly regulated healthcare environment
• Collaborate with international teams and leading pharmaceutical customers
• Help shape the future of contamination control and sterility assurance across a growing global organization

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

www.datwyler.com