Validation engineer - temporary role - San Vittore

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

The validation engineer is critical in ensuring that all validation activities are executed in compliance with regulatory

standards and Baxter's internal quality requirements. The validation engineer will work closely with cross-functional

teams to develop, implement, and maintain validation protocols and documentation.

WHAT YOU'LL BE DOING:

Validation Planning: Develop and execute validation plans for the Line 2 downstream upgrade project,

ensuring alignment with project timelines and regulatory requirements.

· Protocol Development: Create, review, and approve validation protocols, including Installation Qualification

(IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.

· Execution of Validation Activities: Conduct validation activities, including testing and data analysis, to

ensure that all systems and processes meet defined specifications and performance criteria.

· Collaboration: Work closely with engineering, manufacturing and quality teams to ensure seamless

integration of validation activities into the project lifecycle.

· Documentation: Maintain accurate and comprehensive validation documentation, including reports,

deviations, and change controls, in accordance with Good Manufacturing Practices (GMP) and Baxter's

quality standards.

· Risk Assessment: Perform risk assessments related to validation activities and implement appropriate

mitigation strategies.

· Training and Support: Provide training and support team members on validation processes and best

practices.

· Continuous Improvement: Identify opportunities for process improvements and contribute to the

development of validation strategies that enhance efficiency and compliance.

WHAT YOU'LL BRING:

Bachelor’s degree in engineering, Life Sciences, or a related field good knowledge of English language

Minimum of 3 years of experience in validation engineering within the pharmaceutical, biotechnology, or medical

device industries, with a focus on downstream processing

Strong understanding of validation principles and quality systems (ISO, cGMP).