RICORLITO RICK VIOS
Elk Grove,CA
Summary
Diligent and successful Senior Manufacturing Technician/Associate brings 20 years of experience in pharmaceutical manufacturing and cell culture process with effective troubleshooting, diagnosis, and task prioritization. Identify malfunctions and implement quick solutions to reduce downtime. GMP-certified with proficiency in aseptic technique, CART-T cell process, powder spray drying, capsule filling, SAP inventory, and production scheduling.
Overview
20
20
years of professional experience
Work History
Manufacturing Associate III
Lonza Biologics
Hayward, CA
08.2022 - Current
- Independently perform laboratory tasks, including pH testing, conductivity testing, filter integrity testing, A280 protein concentration testing, product sampling, and conduct routine sanitization tasks to maintain facility and equipment.
- Independently perform downstream equipments such as AKTAprocess, AKTAready, SUTFF(Single Use Tangential Flow Filtration System, Manual TTF(Tangential Flow Filtration System for Ultra filtration and Diafiltration and Coupling Equipment.
- Demonstrate expertise and breadth of knowledge on process flow and in executing process recipes across variety of production aseptic activities.
- Adherence to cGMPs, written procedures (SOPs), housekeeping, 6S, use of electronic document and inventory systems (DMS/SAP), monitoring equipment and processes, product sampling, and equipment sanitization tasks.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Monitored employee actions for adherence to safety procedures.
- Perform Bulk Filling activities.
- Escalates process challenges and proposes solutions
Senior Manufacturing Technician
Novartis | Mylan | Viatris Pharmaceutical
04.2016 - 01.2022
- Led, trained, mentored and provided work direction to new and existing employee on processes (dispensing, equilibration, spray drying, capsule filling, and packaging activities)
- Cleaned, maintained, assembled, operated, and troubleshoot manufacturing equipment per SOP's (Spray Drying and Filling Equipment)
- Calibrated machines to maintain required productivity levels and adherence to quality standards
- Ensured that products were produced on time and of good quality
- Built product subassemblies or final assemblies and monitored and adjusted production processes or equipment for quality and productivity
- Strived for continues process improvement by speaking up for Safety and Quality matters
- Addressed quality and safety CAPA's by participating in deviation management and root cause analysis investigations
- Completed manufacturing operations activities such as spray drying, filling, and packaging
Aseptic Trainer
Novartis Pharmaceuticals
07.2018 - 07.2019
- Administered aseptic behavior certification program for employees working in manufacturing aseptic environment including supporting cleaning staff, facilities staff etc
- Support Cell Processing Specialist trainer during training simulated manufacturing environment (CAR-T cell process)
- Coached, mentored and trained on aseptic technique related to gowning for Grade B (ISO 7) and environmental monitoring (MetOne, SAS, Contact Plates)
- Managed Aseptic Gowning Qualification program; improved training methods and reduced qualification failure rate from 25% to 75%
- Supported and trained on set up, process and cleaning on Cell Saver 5, Wave Bioreactor, Sepax Cell separation system, Centrifuge, Incubator, Biological Safety Cabinet, Met One particle counter, SAS, RODAC contact plating and NucleoCounter NC-200 counter
- Trained and verified that trainees were using correct equipment associated with process and ensure trainees are using them correctly per SOP's
- Contributed with Manufacturing and Quality Assurance to develop action plans for employees showing alert limits in garment sampling to improve technique
- Provided GDP, GMP and safety couching as needed
- Used LIMS, SAP when needed per batch record
Senior Manufacturing Technician | III | II
Novartis Pharmaceutical
03.2006 - 04.2016
- Performed activities developing manufacturing product and marketing of prescription drug products for treatment of respiratory diseases and genetic disorder in accordance with Standard Operating Procedures
- Performed production activities (Clean in Place, device assemblies, tank cleaning and Filter Testing) prepared spray dryer and capsule filling for commercial activities and manufacturing equipment as defined by Batch Production Records
- Monitored production equipment operation and performed troubleshooting and diagnosis of malfunctions
- Coordinated action plans at cross-functional meetings and communicated issues with team members to drive corrective actions
- Developed improvement methods and practices to increase quality and productivity
- Updated senior management on filling and spray drying project progress
- Contributed to manufacturing process improvements to meet production deadlines
- Performed production scheduling, pass down, and workflow coordination
- Set up safety equipment and verified proper functionality to minimize future hazards
- Trained, mentored, provided work direction to new and existing employee on equipment and SOP's.
Manufacturing Technician II | I
Impax Laboratories
02.2003 - 03.2006
- Compounded active pharmaceutical ingredients, in pharmaceutical manufacturing process in FDA regulated environment utilizing coating, milling, and blending Technology in accordance with Standard Operating Procedures
- Weighed and dispensed active pharmaceutical ingredients
- Monitored production equipment operation and performs troubleshooting and diagnosis of malfunctions
- Completed basic repairs to restore performance of malfunctioning machine
- Read and understood production batch record to complete accurate work and minimize wasted resources
- Set up, calibrated and continuously adjusted production equipment to achieve desired production speed and material flow
- Inspected finished products to verify conformity to quality standards
Education
Undergraduate - Computer Science And Programming
Asian College of Technology
Cebu, PhilippinesHigh School Diploma -
University of San Jose-Recoletos
Cebu, Philippines03.1993
Skills
- Cross-functional Team Leadership Aseptic trainer CAR-T Cell Process Cell Culture
- Process Implementation Spray Drying and Filling Downstream Filtration Data Integrity, GMP, GDP Team Collaboration
- TECHNICAL SKILLS
- Proficient in Oracle Application, SAP, LIMS and ESOP
- Filter Integrity, pH meter, Density Testing (Horiba), Protein Concentration Testing(A280)
- Pi Coresight
Timeline
Manufacturing Associate III
Lonza Biologics
08.2022 - Current
Aseptic Trainer
Novartis Pharmaceuticals
07.2018 - 07.2019
Senior Manufacturing Technician
Novartis | Mylan | Viatris Pharmaceutical
04.2016 - 01.2022
Senior Manufacturing Technician | III | II
Novartis Pharmaceutical
03.2006 - 04.2016
Manufacturing Technician II | I
Impax Laboratories
02.2003 - 03.2006
Undergraduate - Computer Science And Programming
Asian College of Technology
High School Diploma -
University of San Jose-Recoletos