Process Expert - Comecer Lines

Major accountabilities:

• Responsibilities include but not are limited to:
• Support a culture of safety, quality, diversity, and inclusion.
• Provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Track and trend critical process parameters and in process checks as part of ongoing process verification (OPV) and identify CAPAs to address any trends.
• Identify, assess, and own technical changes through GMP change control processes.
• Investigate deviations and determine root causes and identify CAPA.
• Act as Subject Matter Expert (SME) for process flow and support data gathering for Annual Product Review.
• Ensure processes are inspection ready at all times.
• Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.
• Support on going self learning and ensuring training is up to date.
• Provide support to production team through training and knowledge sharing.

Minimum Requirements:

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or other science related fields or equivalent experience.
• 1+ years of experience in a manufacturing environment, preferably in pharmaceutical manufacturing
• Direct experience in a GMP or aseptic/sterile environment is highly desired.
• Radio pharma experience is a plus
• Word, Excel, Powerpoint, and Teams Experience
• Ability to work in a cross functional team
• Technical writing experience preferred
• Excellent communication skills
• English fluently, verbally and in writing

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.