Senior Quality Engineer - Microbiology, Sterility & Contamination Control

Datwyler Group; Pregnana Milanese; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work options

Continuous learning

Development opportunities

Descrizione del lavoro

Datwyler Group in Italy is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to shape microbiological quality across the manufacturing network. You will lead testing programs, drive sterility assurance, and manage contamination control as part of global QA initiatives.

The role requires a PhD or MSc with 10+ years experience, strong GMP knowledge, and leadership in a multinational environment.

Competenze

• 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, any other language is a plus.

Mansioni

• Lead global Contamination Control Strategy (CCS) aligned with EU GMP Annex 1.
• Drive microbiological risk assessments and define contamination prevention measures.
• Provide technical leadership on microbiological testing (bioburden, endotoxin, sterility).
• Define environmental monitoring and cleanroom control across sites.
• Develop global sterility assurance approaches for primary packaging components.
• Support validation of sterilization, cleaning, washing, and packaging processes.
• Lead complex microbiological investigations and CAPA activities.
• Collaborate with cross-functional teams to improve quality and compliance.

Conoscenze

Microbiology

Sterility

Contamination control

Process validation

GMP knowledge

Regulatory knowledge

Technical leadership

English fluency

Formazione

Master's degree in Microbiology

PhD in related field

Descrizione del lavoro

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

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 act as the global Subject Matter Expert (SME), shaping and advancing our approach to microbiological quality, sterility assurance, and contamination control throughout our manufacturing network. This is a unique opportunity to make a meaningful impact on product quality, regulatory compliance, and ultimately patient safety. You will drive the development and continuous improvement of robust strategies, programs, and systems covering microbiological testing, sterility assurance, and contamination control across products, manufacturing processes, sterilization technologies, and supply chain activities. Working closely with colleagues in Quality, R&D, Manufacturing, Engineering, Regulatory Affairs, and Operations, you will establish best practices, provide expert guidance, and help ensure alignment 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 We’re Looking For

• 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, any other language is a plus.

What We Offer

• Attractive compensation package that rewards your expertise and impact.
• Flexible working arrangements with hybrid options to support a healthy work-life balance.
• Continuous learning and development opportunities to help you grow your skills and advance your career.
• The chance to work with cutting-edge technologies across exciting, fast-evolving industries.
• A collaborative, high-performing team environment where your ideas and contributions truly make a difference.

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