Manufacturing Specialist (Deviation Investigations)

About the role

Novartis is hiring a Manufacturing Specialist (Band Level 3) in Mexico City, Mexico, working in a hybrid setting. The role leads deviation and investigation work end-to-end: assessing criticality and product impact, writing robust investigations, driving root-cause analysis and turning findings into effective Corrective and Preventive Actions implemented through Good Manufacturing Practice systems. It also covers generating manufacturing orders in the Manufacturing Execution System and delivering targeted training on quality behavior. Relocation support is not offered.

Key responsibilities

• Open and assess deviations within defined timelines, evaluating their criticality and product impact in line with batch release activities
• Author and own investigations, defining clear scope, root cause and timely closure
• Apply structured root cause analysis tools to identify product and process deviations
• Develop, document and implement Corrective and Preventive Actions, and verify their effectiveness
• Run experiments or manufacturing runs to support investigation outcomes
• Work cross-functionally to keep production compliant during deviations
• Generate manufacturing orders in the Manufacturing Execution System as required
• Deliver training to reinforce quality practices and compliance standards

Required profile

• Bachelor's degree in a scientific field, with two to five years of pharmaceutical industry experience
• Proven experience in a GMP production environment, preferably aseptic or sterile
• Demonstrated experience leading deviation investigations and CAPA activities
• Knowledge of current GMP regulations and pharmaceutical manufacturing regulatory expectations
• Fluent written and spoken English and Spanish
• Willingness to join a rotating shift model with weekend work, keeping five days per week

Required skills

• Good Manufacturing Practices (GMP)
• Structured root cause analysis methods
• Business processes and data analytics