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.When something unexpected happens in manufacturing, you'll be the person who brings clarity, structure, and momentum - so production can continue compliantly and patients aren't kept waiting.
In this role, you'll lead deviation and investigation work end-to-end: assessing criticality and product impact, authoring robust investigations, and driving root-cause analysis using practical investigation tools.
You'll translate findings into effective Corrective and Preventive Actions, ensure implementation through Good Manufacturing Practice systems, and verify that actions truly prevent recurrence.
You'll also support the operation by generating manufacturing orders in the Manufacturing Execution System when needed and delivering targeted training that reinforces strong quality behaviors.Job Description Key ResponsibilitiesOpen and assess deviations, determining criticality within defined timelinesEvaluate product impact of deviations in alignment with batch release activitiesAuthor and own investigations, ensuring clear scope, root cause, and timely closureApply structured root cause analysis tools to identify product and process deviationsDevelop, document,



and implement effective Corrective and Preventive ActionsVerify robustness and effectiveness of critical and major investigationsExecute experiments or manufacturing runs to support investigation outcomesCollaborate cross-functionally to ensure compliant production during deviationsGenerate manufacturing orders within the Manufacturing Execution System as requiredDeliver targeted training to reinforce quality practices and compliance standardsEssential RequirementsBachelor's degree in a scientific field, with two to five years of pharmaceutical industry experienceProven experience working in a Good Manufacturing Practice production environment, preferably aseptic or sterileDemonstrated experience leading deviation investigations and corrective and preventive action activitiesStrong knowledge of current Good Manufacturing Practice regulations and regulatory expectations for pharmaceutical manufacturingExperience applying structured root cause analysis methods to product and process issuesFluent English and Spanish communication skills, both written and spokenThis role includes participation in a rotating shift model, which involves work on weekends for part of the schedule, with overall working time remaining five days per week and details agreed in advance.Commitment to Diversity and InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.Accessibility and accommodationNovartis 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 ****** and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.Skills DesiredBusiness Processes, Data Analytics, digital skills (Inactive), General Hse Knowledge (Inactive), Good Manufacturing Practices (GMP), Resilience#J-*****-Ljbffr

📌 Manufacturing Specialist (Xico)
🏢 MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de
📍 Xico