Packaging Process Engineer Specialist @ Novartis Vaccines and Diagnostics
Packaging Process Engineer - Technical Leadership Program @ Novartis Vaccines and Diagnostics
Bachelor's Degree, Medical engineering, Ingegneria biomedica/medica @
Università di Roma Tor Vergata
I'm a Medical Engineer with a strong background in Research and Development. From the beginning of my university studies, I've studied and worked at the same time developing the ability to fully integrate my professional and personal life. This allowed me to develop self-confidence and increase my understanding of the professional environment. During University I worked for
I'm a Medical Engineer with a strong background in Research and Development. From the beginning of my university studies, I've studied and worked at the same time developing the ability to fully integrate my professional and personal life. This allowed me to develop self-confidence and increase my understanding of the professional environment. During University I worked for 4 years on mammalian stem cell cultures and tissue engineering in the laboratories of Medicine and Biochemistry of the University of Rome, Tor Vergata.
Once finished the University I worked all around the Europe in multidisciplinary teams as a Validation Engineer for Pharma Quality Europe a Contract Quality Organization serving main European Pharma, Biotech and Medical Devices industries.
In 2012 I joined Novartis Vaccines & Diagnostics as a Project Engineer and as a member of the Technical Leadeship Program a talent program that provides job rotations in the main company departments for the first two years.
In 2012 I joined Novartis Vaccines & Diagnostics in Siena (Italy) in the biggest Production Site of the Division with almost 3000 employees. I joined the organization as a Project Engineer and as a member of the Technical Leadeship Program a talent program that provides job rotations in the main company departments for the first two years covering different position from quality to operations. Thus allowed me to know the manufacturing production, primary and secondary operations
At the end of the program I landed in the Packaging Department as Process Engineer Specialist and in a Top Priority Company Product Team as Team Coordinator and SME.
Strong oriented to problem solving and focused to result.
Love to learn about cultures and people.
MES Program Manager @ Responsible for executing the MES implementation in Packaging Dept. on time and on budget ensuring the transition from a Paper Batch Record to an Electronic Batch Record for each Packaging Line.
To coordinate all the activities and communications to the top management.
To address activities/issues of the team in order to establish and maintain plans (time & budget) of projects included the roadmap.
To control the progress against the plans suggesting agreed corrective actions to top management.
Ensuring the system validation and change management is accomplished properly, in compliance with the GMP.
Process optimization to reduce batch change time, production duration and Batch Record review workload (Value Stream Mapping and FMEA analysis).
Werum PAS-X sytem Upgrade. System interface to SAP, Labeling System and OSI-PI Data Historian. Field integration via Kepware. Production Lines Automation. From March 2015 to Present (10 months) Siena Area, ItalyPackaging Process Engineer Specialist @ Lean Six Sigma - Black Belt
Coordinator of all Packaging activities involved in a New Bacterial Vaccine Launch for B Meningitis from regulatory requirements to artwork specifications and production processes. Developing aligned strategies with Supply Chain for the product launch in new Countries.
Project Manager: Continuous Improvement Projects & Product Team Projects. CARs submission and related budget for Packaging Department (sterile Vials and PFS).
Automation: utilize Line Automation and MES system to generate and visualize in automatic way Packaging Lines KPIs (OEE, MTBF, Schedule Adherence, Average Speed, Loss Tree Analysis).
Continuous improvement: Kaizen and GEMBA approach, Lean Processes / Manufacturing, SMED.
Support to Production: Materials Subject Matter Expert, solve design/process issues, evaluate risk/failure mode and implement appropriate change. Owner of Change Requests, coordinator of the related Validation and Qualification activities.
Support to Quality Assurance: Manage Change Request in accordance with GMP, Technical Investigations/Reports for DRs, Root Cause Analysis, Value Stream Mapping, FMEA and Risk Assessment. From April 2014 to 2015 (1 year) Siena Area, ItalyPackaging Process Engineer - Technical Leadership Program @ Lean Six Sigma, Green Belt - Improve Packaging Line productivity through Kaizen
I’m accountable of Packaging Production Lines KPIs creation (Availability, Productivity, OEE, MTBF) and all the Change Request from paperly BPR to EBR (Electronic BPR).
Automated data gathering from MES and directly from the machines via Keepware through Osi-Pi.
MES in Packaging - Werum PAS-X. Interfaced to SAP, Labeling System and OSI-PI Data Historian. Field integration via Kepware. Production Lines Automation and EBR.
I’m leading Kaizen, GEMBA and Lean Projects in Packaging Department working closely to operators and maintainers to reduce waste and improve Packaging Lines efficiency.
I'm accountable of Continuous Improvement, Change Requests and related IQ, OQ, PQ for Packaging Department (sterile Vials and PFS), Projects Budget and Supplier Dealings as well. Working and interfacing with Supply Chain to analyze and review the Packaging Lines Capacity. From April 2013 to April 2014 (1 year 1 month) Quality Assurance on the Shop Floor - Technical Leadership Program @ DR/CAPA Owner and BPR Review for Primary Bacterial Segment - Fermentation, Ultrafiltration, Purification, Media & Buffer.
Root Cause Analysis, Processes Mapping, Statistical Analysis, GAMP, GMP, 21 CFR Part 11/820 Conformity.
Compliance: FDA, EMA, Annual Product Review, GMP inspection auditor From 2012 to 2013 (1 year) Toscana, ItalySupply Chain / Operational Excellence - Technical Leadership Program @ Innovation Quality Productivity, Warehouse: reduce costs, optimize processes, OTIF improvement
GEMBA 5S in Warehouse: improve the workplace organization and safety reducing product mix-up
Kaizen approach in Packaging: reducing changeover time
Support Supply Chain in Projects/Business cases, FMEA Analysis, Statistical Analysis, Value Stream Mapping, Visual Management From April 2012 to 2012 (less than a year) Validation Engineer - Consultant @ Computer System Validation: ERP systems; Process Control System, Manufacturing and Packaging Equipments; Laboratory Systems, Infrastructure.
Technical Qualification: HVAC, Laboratory Systems, Production Chain Systems, Process Equipment, Molding, Medical Devices
Pharmacovigilance, SOPs, GAMP; GMP, 21 CFR Part 11/820 - Annex 11 Conformity. Processes Mapping and Analysis.
Work experiences abroad as a member of multidisciplinary team in major European Pharmaceutical & Medical Device Industries From 2010 to 2012 (2 years) Research & Development @ Identification, characterization and differentiation of stem cells from peripheral blood of mammals (mammalian cell cultures). Tissue Engineering (Bone, Skin, Brain, Liver)
Using optical and confocal microscopes, using flow cytometry. Applications of stem cells in prosthetic osseointegration. Reserch on new biocompatible materials. Reserch on new drugs to optimize stem cells differentiation.
Repair equipment and technical assistance in the Medicine and Biochemistry department.
Manager of a small team of students. From 2007 to 2010 (3 years)
Master's Degree, Medical Engineering @ Università di Roma Tor Vergata From 2008 to 2010 Bachelor's Degree, Medical engineering, Ingegneria biomedica/medica @ Università di Roma Tor Vergata From 2005 to 2008 Flavio Acri is skilled in: GMP, Quality Assurance, FDA, Supply Chain Optimization, 5S, Gemba Kaizen, Warehouse Management, FMEA, Minitab, Process Engineering, Packaging Engineering, Biomedical Instrumentation, Motion Analysis, Kinematics, Biomedical Engineering
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