Manufacturing Specialist

Novartis; Ciudad de México; Híbrido; MXN 480.000 - 640.000; Jornada completa

Descripción de la vacante

Novartis in Mexico City is seeking a quality-focused Manufacturing Deviation Investigator to drive investigations and CAPAs within GMP. You will lead end-to-end deviation work, assess product impact, and translate findings into effective corrective actions, ensuring robust prevention of recurrence.

The role requires leadership in root-cause analysis, collaboration across functions, and weekend rotation with five-day weeks. Fluency in English and Spanish is essential.

Formación

• Bachelor's degree in a scientific field with 2–5 years in pharma.
• Proven GMP production experience, aseptic/sterile preferred.
• Experience leading deviation investigations and CAPAs.
• Fluent in English and Spanish, written and spoken.

Responsabilidades

• Open and assess deviations, determining criticality within timelines.
• Evaluate product impact in line with batch release activities.
• Author and own investigations with clear scope and root cause.
• Apply root cause analysis to identify deviations in product and process.
• Develop and implement CAPAs; verify effectiveness.
• Support manufacturing operations during deviations and train staff.

Conocimientos

Deviation investigations

GMP experience

Root cause analysis

Bilingual English/Spanish

Shift work

Educación

Bachelor's degree in science

Descripción del empleo

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 Responsibilities

• Open and assess deviations, determining criticality within defined timelines
• Evaluate product impact of deviations in alignment with batch release activities
• Author and own investigations, ensuring clear scope, root cause, and timely closure
• Apply structured root cause analysis tools to identify product and process deviations
• Develop, document, and implement effective Corrective and Preventive Actions
• Verify robustness and effectiveness of critical and major investigations
• Execute experiments or manufacturing runs to support investigation outcomes
• Collaborate cross-functionally to ensure compliant production during deviations
• Generate manufacturing orders within the Manufacturing Execution System as required
• Deliver targeted training to reinforce quality practices and compliance standards

Essential Requirements

• Bachelor's degree in a scientific field, with two to five years of pharmaceutical industry experience
• Proven experience working in a Good Manufacturing Practice production environment, preferably aseptic or sterile
• Demonstrated experience leading deviation investigations and corrective and preventive action activities
• Strong knowledge of current Good Manufacturing Practice regulations and regulatory expectations for pharmaceutical manufacturing
• Experience applying structured root cause analysis methods to product and process issues
• Fluent English and Spanish communication skills, both written and spoken
• This 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 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