Manufacturing Specialist

Band

Level 3

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 tas.mexico@novartis.com 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