Steven Dugo
Aseptic Vaccine Operator
Rochelle Park, NJ 07662
*****.****@***.*** - 201-***-****
Ambitious professional with a long history of comprehensive experience in a high volume manufacturing environment. Highly knowledgeable in all areas of production as well as regulatory safety and compliance. A passionate, motivated individual who has an excellent sense of teamwork. Authorized to work in the US for any employer
WORK EXPERIENCE
Aseptic Vaccine Operator, Biotech/Vaccines
Pfizer - Pearl River, NY - March 1991 to July 2016 Responsibilities include: operating and monitoring production, labeling, packaging and cartooning equipment used in syringe and vial inspection and fill/finish. Maintain logs/batch records. Work with Media Fill staff to assure product quality.
Grade classifications of aseptic techniques A,B,C,D in a clean-room environment. Gown Certified. Transfer production and packaging supplies from holding areas to aseptic production areas. Perform component preparation that includes: perform vacuum leak and bowie dick testing on autoclaves, sterilize,unload, wrap, and tag sterilized parts and place in storage. Set-up Operator/Mechanic
Pfizer Inc. - Pearl River, NY - 2011 to 2016
Within vial vaccine manufacturing, responsible for troubleshooting computer system electronics and set up, calibrate, operate, maintain, clean, repair, preventative maintenance (PMOs), diagnose and trouble shoot sterile production equipment adhering to specific requirements.
- Function in aseptic environment, maintaining gown certification
- Operate WFI Water System
- Prepare and wrap sterile transfers, needles and pump assembly
- Run media fills
- Run validation batches and maintain batch records, reporting deviations
- As part of QC, perform air quality, surface, and personnel monitoring and sampling
- Perform building walk-around to inspect Trane and Carrier chillers, air handling unites, and Glycol pumps
Set-up Worker, Consumer Health-A division of Pfizer Pfizer - Pearl River, NY - 1996 to 2011
- Responsible for troubleshooting computer electronics
- Responsible to set up, operate, maintain, adjust, disassemble, clean, repair, preventative maintenance (PMOs), diagnose and trouble shoot production equipment and tooling
(turret & tooling changes)
- Issued tooling for production runs including batch records
- Equipment used included: scales, balances, diagnostic equipment, tablet press, computers, forklifts, tooling polisher, sonic bath, tooling defacer, turret hoist and lifts, basic hand tools, and metal detectors
- Managed multiple production machines during shift productively including setup of future orders
- Run validation batches in collaboration with lab and tech services
- Receive or move materials; maintain records/ logbooks
- Report deviations from procedures to Supervisor
- Train personnel on the operation of production machinery. Mason, Maintenance
Pfizer - New York, NY - 1991 to 1996
New Jersey/ New York City
- Masonry work included: interior and exterior plastering, concrete, brick/block, epoxy flooring and tile work for a 600 acre campus
Bricklayer, Journeyman
Bricklayers & Allied Craftsmen Local 4 - Morristown, NJ - 1981 to 1991 Handled commercial and residential foundation and general building masonry construction for New Jersey and New York City area.
EDUCATION
Saddle Brook Mid High School - Saddle Brook, NJ
1974 to 1978
SKILLS
Packaging Operator, Sap Labware, cGMPs, Aseptic Technique, Forklift Operator, Media Preparation, Contamination Control
CERTIFICATIONS
Aseptic Gowning and Clean room behavior
Forklift Certified
ADDITIONAL INFORMATION
SKILLS & TRAINING
- Quality Assurance/ Control (QA) - Product Verification Inspection
(PVI)
- Lock out/ Tag out - In Process Checks (IPC)
- Line Staging - 5S Methodology
TECHNICAL SKILLS
- AMPS - AWACS
- Maximo - LACES/ LIMS
- Eisai - Plateau
MACHINERY - EQUIPMENT
Biological: Siemens/ Apogee Air Quality Monitoring, Bosch Vial Washer/ Depyrogenator, Eisai Vial Inspector, WFI Water System Trane/ Carrier chillers, air handing units, Glycol pumps
Compression: Stokes 754/328/ BB2, Fette 3200, Kikusui Libra & Gemini Tablet Compressors Transport: Forklift, Hand Jack, Walker Pallet Truck, Straddle Stacker, Hi/Lo