Sterility assurance engineer

CAI; Milano; In loco; EUR 45.000 - 57.000; Tempo pieno

Descrizione del lavoro

CAI in Milano, Italy, seeks an experienced professional for sterility assurance and aseptic process validation to ensure GMP compliance and reliable manufacturing outcomes.

You will manage documentation, coordinate cross-functional activities, and support field execution with attention to detail, strong writing, and proactive problem solving. Travel may be required.

Competenze

• Experience with microbiological and biological methods.
• Strong technical writing and documentation skills.
• Ability to work autonomously and proactively.

Mansioni

• Experience with microbiological and biological methods, including method application and validation.
• Understanding of quality systems, GMP regulations, and Good Documentation Practices.
• Familiarity with Annex 1 requirements and sterile manufacturing principles.
• Experience with aseptic techniques and biological safety cabinets.
• Ability to work independently while managing multiple priorities.
• Strong attention to detail, organizational skills, and problem-solving capabilities.

Conoscenze

Communication skills

Technical writing

Autonomy

Formazione

Bachelor's degree in Life Sciences

Strumenti

Sterile manufacturing equipment

Descrizione del lavoro

CAI Overview:

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

We act with integrity

We serve each other

We serve society

We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing

expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Key Responsibilities:

• Experience with microbiological and biological methods, including method application and validation.
• Understanding of quality systems, GMP regulations, and Good Documentation Practices.
• Familiarity with Annex 1 requirements and sterile manufacturing principles.
• Experience with aseptic techniques and biological safety cabinets.
• Ability to work independently while managing multiple priorities.
• Strong attention to detail, organizational skills, and problem-solving capabilities.

Preferred Profile

• Intermediate level professional with hands-on experience in sterility assurance and aseptic process validation activities.
• Capable of independently managing documentation, coordinating assigned activities, and supporting field execution when required.
• Strong communication and stakeholder management skills.
• Comfortable working in cross-functional and project-based environments.

Essential Requirements

• Proficient in spoken and written English.
• Strong technical writing and documentation skills.
• Ability to work autonomously and proactively.

Willingness to travel domestically and internationally if required.

La selezione rispetta il principio delle pari opportunità (l. 903/77)

€45,000 - €57,000 a year

The compensation package offered ranges from €45,000 to €57,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.