**Summary**:
LI-Hybrid
- Location: Mexico City, Mexico
- 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.
**About the Role**:
**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
- 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
- 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**
**Benefits and Rewards**: Learn about all the ways we'll help you thrive personally and professionally.
- Read our handbook (PDF 30 MB)
Division
Operations
Business Unit
Production / Manufacturing
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Ajustes de accesibilidad**:

📌 Manufacturing Specialist (Xico)
🏢 Novartis
📍 Xico