Facilities Deviation Writer

About this role

Job Description Summary

#LI-Hybrid

Location: Mexico City, Mexico

Relocation Support: This role is based in Mexico City, Mexico. Novartis is unable to offer relocation support: please only apply if accessible.

Take ownership of quality where it truly matters - at the intersection of facilities, engineering, and patient impact. In this role, you will play a key part in ensuring deviations are thoroughly investigated, understood, and resolved, helping to maintain high standards in a complex GMP environment. You’ll work closely with cross-functional teams to drive robust investigations and meaningful corrective actions, while shaping a culture of continuous improvement and quality excellence.

If you enjoy combining analytical thinking with hands-on collaboration, this role offers a chance to make a real difference.

Job Description

Key Responsibilities

• Open and assess deviations within required timelines, ensuring accurate classification and documentation
• Evaluate product impact of deviations, aligning with batch release requirements and quality standards
• Author, own, and drive investigations through to timely and compliant closure; update SOPs as relevant to Deviations/CAPAs
• Apply structured root cause analysis methods to identify causes of process and product deviations
• Ensure investigations are complete, accurate, and fully supported with robust documentation
• Design and execute experiments or studies to support investigation outcomes
• Collaborate cross-functionally to assess deviation impact and maintain compliant operations
• Develop, document, and implement effective corrective and preventive actions
• Monitor CAPA effectiveness and ensure execution through Good Manufacturing Practice systems and training
• Deliver training and communication to reinforce quality practices and maintain compliance

Essential Requirements

• Bachelor’s degree in a relevant field with pharmaceutical industry experience
• Fluency in written and spoken English
• Two to five years of experience in a pharmaceutical, facilities, engineering, or quality environment
• Hands-on experience with deviation management and writing investigations in a GMP environment
• Proven experience in CAPA management, including creation, implementation, and effectiveness tracking
• Strong root cause analysis skills using structured investigation methodologies
• Strong understanding of current good manufacturing practices and regulatory expectations for biologics manufacturing
• Excellent technical writing skills, with the ability to clearly structure investigations and present findings
• Commitment to Diversity and Inclusion
• Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
• Accessibility and accommodation

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to tas.mexico@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

• Skills Desired
• Business Processes, Data Analytics, digital skills (Inactive), General Hse Knowledge   (Inactive), Good Manufacturing Practices (GMP), Resilience