Novartis Pharma Schweiz
Manufacturing Specialist (weekend day shift)
Novartis Pharma Schweiz, Indianapolis, Indiana, us, 46262
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.
Shift Weekend Days - position may involve mandatory overtime as needed.
Responsibilities
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).
Qualifications
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.
Seniority level
Mid-Senior level
Employment type
Part-time
Job function
Management and Manufacturing
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Novartis Pharma Schweiz by 2x.
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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.
Shift Weekend Days - position may involve mandatory overtime as needed.
Responsibilities
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).
Qualifications
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.
Seniority level
Mid-Senior level
Employment type
Part-time
Job function
Management and Manufacturing
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Novartis Pharma Schweiz by 2x.
#J-18808-Ljbffr