Howard Jens

About Howard Jens

Experienced senior manager for technical personnel. Project engineering and project management experience across a broad range of GMP industries including biotech, cell therapy, pharmaceutical, food and consumer products. I have had a wide variety of responsibilities on projects up to $75M. Personable and equitable management style that is strategic, goal-oriented and stresses work-life balance. Experience includes facility and clean room design, process and equipment design, utility systems (GMP and non-GMP) and HVAC design. Extensive experience with cell therapy and biotech equipment, facilities and utility systems, lyophilizers, bioreactors, media/buffer prep and hold vessels, resin-based chromatography systems, CIP and SIP, autoclaves, parts washers, clean-room air handling units, clean gas systems, WFI and RO water systems, clean steam generators, liquid nitrogen systems and differential pressures for ISO classified areas. Excellent understanding of automation, instrumentation and controls including PLC ladder logic, Delta-V and Desigo.

Experience

1. Associate Director, Facilities Engineering

   Kite Pharma

   May 2022 — Present · El Segundo, CA, US

   Manage Project Engineers and Project Managers for capital projects involving facilities, utilities and equipment in a commercial cell therapy manufacturing facility. This includes design, construction, installation and commissioning. Responsible for managing the site capital project portfolio including scope, budget and schedule. My team also supports regulatory audits, change control, deviations and CAPAs.

Education

• John F. Kennedy High School

  High School Diploma

  1979 — 1982

• University of Southern California

  BS, Chemical Engineering

  1982 — 1986

Skills

• Gmp
• Quality System
• V&V
• Process Simulation
• Engineering
• Corrective and Preventive Action (Capa)
• Dmaic
• Leadership
• Chromatography
• Aseptic Processing
• Project Engineering
• Iso 13485
• Standard Operating Procedure (Sop)
• Biopharmaceuticals
• Design Control
• Pharmaceutical Industry
• Fda
• Biotechnology
• Process Engineering
• Design of Experiments
• Manufacturing
• Chemical Engineering
• Cross-Functional Team Leadership
• Medical Devices
• Capa
• Cleaning Validation
• Validation
• 21 Cfr Part 11
• R&D
• Change Control
• U.s. Food and Drug Administration (Fda)
• Technology Transfer
• Quality Assurance