Novartis
pharmaceutical
ManufacturingSpecialist
“Manufacturing Specialist at Novartis. Skills: deviation and investigation work, assessing criticality and product impact, authoring robust investigations, driving root-cause analysis, translating findings into effective Corrective and Preventive Actions, ensure implementation through Good Manufacturing Practice systems, verify that actions truly prevent recurrence, generating manufacturing orders, delivering targeted training. lead deviation and investigation work end-to-end. assessing criticali”
Industry & Context.
root cause analysis; product and process issues
participation in a rotating shift model, which involves work on weekends for part of the schedule
What They're Looking For.
Must Have
Bachelor’s degree in a scientific field, 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, 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, participation in a rotating shift model, which involves work on weekends for part of the schedule
Nice to Have
preferably aseptic or sterile
What You'll Do.
lead deviation and investigation work end-to-end
assessing criticality and product impact
authoring robust investigations
driving root-cause analysis using practical investigation tools
translate findings into effective Corrective and Preventive Actions
ensure implementation through Good Manufacturing Practice systems
verify that actions truly prevent recurrence
support the operation by generating manufacturing orders in the Manufacturing Execution System when needed
delivering targeted training that reinforces quality behaviors
Open and assess deviations
determining criticality within defined timelines
Evaluate product impact of deviations in alignment with batch release activities
Author and own investigations
Apply structured root cause analysis tools to identify product and process deviations
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
Generate manufacturing orders within the Manufacturing Execution System as required
Deliver targeted training to reinforce quality practices and compliance standards
How You'll Work.
Team & Collaboration
Collaborate cross-functionally to ensure compliant production during deviations
Communication Scope
Fluent English and Spanish communication skills, both written and spoken
Process & Methodology
process management
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