Novartis Pharma Schweiz
Manufacturing Specialist (weekend night shift)
Novartis Pharma Schweiz, Indianapolis, Indiana, us, 46262
Manufacturing Specialist (weekend night shift)
Novartis Pharma Schweiz – Indianapolis, IN
Shift: Weekend Nights (may involve mandatory overtime)
Responsibilities
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.
Qualifications
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
#J-18808-Ljbffr
Shift: Weekend Nights (may involve mandatory overtime)
Responsibilities
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.
Qualifications
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
#J-18808-Ljbffr