Manufacturing Specialist; weekend day shift

Join to apply for the Manufacturing Specialist (weekend day shift) role at Novartis Pharma Schweiz

This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Weekend Days - position may involve mandatory overtime as needed.

• Provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements.
• Act as the Subject Matter Expert (SME) for product and process knowledge and be the first point of contact for product and process related issues.
• Drive investigations to true root cause, and implementation of corrective and preventive actions.
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Technical writing/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/Owning investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection ready at all times.
• Support process optimization and new technology introduction for continued productivity improvement.
• Review validation protocols and reports.
• Support the 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 all required guidelines and procedures.
• Participate in assigned qualification/validation activities, as necessary.
• Facilitate a culture of “speaking up” and ensuring 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.
• Ensure overall inspection readiness for area of responsibility.
• Report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
• Training in radiochemistry or radio pharmacy is 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.
• Exploitation of 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.

• Mid-Senior level

• Part-time

• Management and Manufacturing
• Pharmaceutical Manufacturing

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