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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).
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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