Pharmaceutical professional with experience in the Biotech industry with roles in manufacturing and engineering. Well organized, results-oriented leader able to troubleshoot and solve problems quickly and effectively. Capable of modifying, creating and designing systems. Adept at installing, adjusting, maintaining, repairing, or providing technical support for biomedical equipment. Excels at evaluating the safety, efficiency, and effectiveness of biomedical equipment. Proficient in training operators and other personnel on the proper use of equipment. Skills include:
• Cell Culture/Fermentation • Validation • Project Management • Purification/Chromatography • Root Cause Analysis • Change Control • Excel • Word • Visio • Microsoft Project • Deviation/Non-conformist Investigation • Trackwise • DeltaV DCS • Allen-Bradley PLC • ABB DCS • OSI PI EXPERIENCE
AMGEN Corporation, Thousand Oaks, CA 2015 – May, 2019 Senior Engineer
• Managed commissioning and start-up of the Ultrafiltration/Diafiltration (UFDF) system, Harvest Area, CIP System, and all benchtop analytical equipment for the Epogen Manufacturing facility.
• Served as Engineering lead for project to convert Harvest Area system control from ABB to DeltaV and increase level of automation.
• Led cross-functional team to perform a Defense-In-Depth exercise to identify and correct deficiencies in the UFDF system. Implemented corrective actions to improve maintenance and operations.
• Performed Data Integrity Analysis for all analytical equipment and UFDF PLC to ensure compliance with applicable data integrity requirements.
• Designed and implemented automation project for the UFDF System to convert from PLC to DeltaV controls and automate CIP operations resulting in 90% reduction in nonconformances. Greenfield Consulting, Glendale/Thousand Oaks, CA 2014 –2015 Validation Engineer, Baxter BioScience
• Performed pre-commissioning, cycle development, and validation of automated Clean-In-Place Systems for new Building 8 cGMP Manufacturing Facility using DeltaV automation.
• Wrote and executed pre-commissioning and cycle development protocols.
• Performed pre-commissioning, cycle development, and validation of automated Capper System for cGMP Fill Line #1 Manufacturing Suite.
PSC Biotech Consultants
Agensys Pharmaceuticals, Santa Monica, CA (Client) 2012 – 2014 Project Engineer
• Served as Project Engineer in the specification, acquisition, and installation of process equipment for new 120,000 sq. ft. manufacturing facility.
• Managed Capital budget of $4 Million.
• Process equipment included: Ultrafiltration/Diafiltration system, Chromatography skids, Viral Filtration Skid, and Bioreactor systems.
Vincent Pantess firstname.lastname@example.org Page Two
• All process equipment is fully automated with either stand-alone Allen-Bradley RSLogix PLCs or DeltaV distributive control systems.
• Ensured all new systems employed novel single-use technologies. San Vicente Cellars, Camarillo, CA 2007 – Present
• Launched ultra-premium winery producing 600-750 cases a year.
• Managed all wine production, sales, and marketing. AMGEN Corporation, Thousand Oaks, CA 2003 - 2007
Senior Engineer, Safety Engineering Group, Environmental Health and Safety, 2005 – 2007
• Served as Manager of the Pressure Safety Program for the Amgen Thousand Oaks (ATO) Site.
• Led Process Hazard Analysis teams for on-site engineering projects.
• Developed and implemented the High-Level Safety Assessment tool to assess and track all new engineering projects being conducted at the Thousand Oaks site. Senior Specialist, 2003 – 2005
• Functioned as Nonconformance Investigator, Neupogen Manufacturing Facility, Purification Department
• Corrective Action/Preventative Action initiation and closure
• Led investigational teams during root cause investigations
• Reviewed and assessed product data for trends. Collaborated with Process Development to resolve issues and implement solutions
ADDITIONAL RELEVANT EXPERIENCE
AMGEN Corporation, Thousand Oaks, CA
Technical Engineering Specialist III
Production Supervisor I/II
Manufacturing Associate I/II/III
United States Navy
Nuclear Engineering Laboratory Technician/Machinists Mate EDUCATION
Bachelor of Science in Cell and Molecular Biology
San Francisco State University