Novartis
manufacturing
ManufacturingSystemsExpert
“Manufacturing Systems Expert at Novartis. Skills: Manufacturing Systems Expert, electronic batch records, manufacturing execution systems, continuous improvement. Define user requirement specifications by capturing and translating the voice of the customer.. Maintain and update electronic batch records with focus on quality, cost, and timelines.”
What You'll Achieve.
transforming complex manufacturing processes into reliable, compliant, and efficient digital solutions; shaping and optimizing electronic batch records and manufacturing execution systems; drive continuous improvement on the shop floor—ensuring operational excellence, regulatory compliance; making a meaningful difference in patients’ lives
Industry & Context.
troubleshooting
Relocation Support: This role is based in Târgu Mureș, Romania. Novartis is unable to offer relocation support: please only apply if accessible.
What They're Looking For.
Must Have
Minimum five years of experience in a Good Manufacturing Practice manufacturing process support role., Proven experience working as a Manufacturing Execution Systems expert in a production environment., University degree in a scientific or technical field such as Pharmacy, Chemical Engineering, or Pharmaceutical Technology, Engineering or equivalent experience., scientific and technical understanding with solid knowledge of automation systems., Good understanding of regulatory requirements across multiple health authorities and compliance standards., Proven ability to work collaboratively in teams, with adaptability and ability to perform under pressure.
What You'll Do.
Define user requirement specifications by capturing and translating the voice of the customer.
Maintain and update electronic batch records with focus on quality
Perform master batch record
and recipe updates in production systems.
Participate in qualification and risk assessment activities for manufacturing systems.
Validate and align technical solutions with Information Technology
Manage manufacturing documentation updates following electronic batch record implementation.
Ensure timely handling of deviations and change controls in compliance with regulations.
Support shop floor operations through troubleshooting
and continuous process improvement.
How You'll Work.
Team & Collaboration
Working closely with cross-functional experts across production, automation, and quality; Validate and align technical solutions with Information Technology, Automation, and Quality teams.; Proven ability to work collaboratively in teams
Communication Scope
capturing and translating the voice of the customer
Process & Methodology
process management, resource planning
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