Manufacturing Specialist; weekend night shift

Manufacturing Specialist (weekend night shift)

Novartis Pharma Schweiz – Indianapolis, IN

Shift: Weekend Nights (may involve mandatory overtime)

• Provide front line support to manufacturing, working with production teams to ensure each batch is manufactured safely and in compliance with batch instructions and quality requirements.
• Act as subject matter expert (SME) for product and process knowledge and serve as first point of contact for product and process related issues.
• Investigate root causes and implement corrective and preventive actions.
• Manage and maintain manufacturing documentation including Master Batch Records, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Technical writing and reviewing to support manufacturing operations, including Standard Operating Procedures (SOP), batch records and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance, and implementation of CAPAs.
• Authoring and owning investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection ready at all times.
• Support process optimization and introduce new technology for productivity improvement.
• Review validation protocols and reports.
• Support execution of process validations and short-term improvement projects.
• Provide guidance and support to production team through training and knowledge sharing.
• Demonstrate leadership capabilities and guide processes to closure/completion while following required guidelines and procedures.
• Participate in assigned qualification/validation activities as necessary.
• Facilitate a culture of “speaking up” and ensure all cGMP compliance activities are followed.
• Prepare applicable documents and records such as batch records, shipping documents, and training materials.
• Participate in periodic mandatory overtime to ensure process continuity and completion.
• Other duties may be assigned as necessary.
• Ensure overall inspection readiness for area of responsibility.
• Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
• Distribute marketing samples where applicable.

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience.
• Training in radiochemistry or radio pharmacy preferred.
• 3+ years’ experience in a process support shop-floor role in GMP manufacturing and/or QA/QC.
• Strong awareness of quality issues.
• Compliance investigations experience required.
• Good understanding of manufacturing and validation requirements and activities.
• Ability to exploit new technology and techniques to eliminate non-value-adding activities and improve productivity/performance through new processes.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.

Seniority Level: Mid-Senior level

Employment Type:

Part-time

Job Function:
Management and Manufacturing

Industry: Pharmaceutical Manufacturing