Manufacturing Specialist

Job Description Summary

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