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Novartis

Manufacturing Specialist

Novartis is hiring a Manufacturing Specialist. Level rates it ; you can apply on Novartis.

Level's read on this job

  • Level rates this role Little AI ●○○○: aI is not part of the work.
  • The posting mentions Manufacturing Execution System, root cause analysis and gmp among its tools and skills.
  • Level classes it as a mid-level role.
  • Novartis has 846 other open roles on Level.

AI in this role

Manufacturing specialist needed to lead deviation investigations, root-cause analysis, and GMP compliance in Mexico City.

manufacturing-execution-system
root-cause-analysisgmpdeviation-investigationquality-assurance

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

How we rate this

Manufacturing Specialist at Novartis rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

  1. ●●●● Builds AI80 to 100
  2. ●●●○ Works on AI60 to 79
  3. ●●○○ Uses AI40 to 59
  4. ●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Root Cause AnalysisGmpDeviation InvestigationQuality AssuranceManufacturing Execution System

Questions you could be asked

  1. Tell me about a project where root cause analysis was part of your work. What did you do?
  2. Tell me about a project where gmp was part of your work. What did you do?
  3. Tell me about a project where deviation investigation was part of your work. What did you do?
  4. Tell me about a project where quality assurance was part of your work. What did you do?
  5. Walk me through how you've used Manufacturing Execution System in your day-to-day work.

Adapt your resume

  • List these exact terms on your resume: Root Cause Analysis, Gmp, Deviation Investigation, Quality Assurance, and Manufacturing Execution System. An applicant tracking system matches the wording, not the idea.
  • Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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