Facilities Deviation Writer

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.; Ciudad de México; Hybrid; MXN 520,000 - 760,000; Full time

Job summary

Novartis in Mexico City is seeking a Deviations Investigator to join the quality, facilities, and engineering team within a GMP environment. You will open and assess deviations, classify and document them, and support batch release while meeting quality standards.

You will lead investigations to closure, develop CAPAs, update SOPs, and ensure robust documentation. You’ll collaborate across functions and deliver training to reinforce quality practices and regulatory alignment.

Qualifications

• Bachelor’s degree in a relevant field with pharmaceutical industry experience.
• Fluency in written and spoken English.
• 2–5 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.

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.

Skills

Fluency in English

GMP knowledge

Root cause analysis

Investigations writing

CAPA management

Technical writing

Education

Bachelor’s degree in a relevant field

Job description

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.

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 [e-mail] 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