Manufacturing Specialist

Novartis; Guamúchil; Vor Ort; MXN 500.000 - 750.000; Vollzeit

Zusammenfassung

Novartis Mexico City is seeking an experienced quality investigator to lead deviation investigations and CAPA activities in a GMP environment. The role requires coordinating cross-functional teams, assessing product impact, and ensuring timely closure of investigations to maintain compliant production.

The candidate will work in a rotating shift with occasional weekend responsibilities, and will generate manufacturing orders as needed while delivering targeted training to enhance quality and

Qualifikationen

• Bachelor’s degree in a scientific field.
• 2–5 years of pharmaceutical industry experience.
• Experience in Good Manufacturing Practice production environment, preferably aseptic or sterile.
• Experience leading deviation investigations and CAPA activities.
• Strong knowledge of GMP regulations and regulatory expectations for pharmaceutical manufacturing.
• Fluent English and Spanish communication skills.

Aufgaben

• 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.

Kenntnisse

Deviation investigations

Root cause analysis

GMP knowledge

Quality mindset

Bilingual English/Spanish

Ausbildung

Bachelor’s degree in a scientific field

Jobbeschreibung

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

Data Analytics, digital skills, General Hse Knowledge, gmp knowledge, process excellence, Resilience