Andrew Harris

About Andrew Harris

Engineer with 20 years of experience in commercial-scale biologics manufacturing of BDS & …

Experience

1. Principal Engineer

   Lonza

   Sep 2020 — Present

   Site Technical Leader: •• Function as site’s technical expert on process equipment & unit operations in both USP & DSP, CIP/SIP, microbial controls, and sanitary equipment design, to internal cross functional groups and external customers. •• Provide technical leadership & consulting using engineering principles to support design & scope for strategic projects of wide range of scales: Functional area projects of facility & process equipment Large strategic CAPEX projects – New facilities, new process facility fit, etc • Technical Authority - Owner of site-wide Engineering & Design standards. Author and revise standards as required. Foster alignment on practices across site assets. • Represent Engineering in Quality Functions: •• Complex/critical cross-asset deviation investigations •• Evaluate proposed changes to the facility as part of Change Control Committee •• Represent Lonza in regulatory inspections and Lonza’s customers when required to justify Engineering practices or complex designs • Network & Industry engagement: •• Technical consultant to the global mammalian network for sanitary equipment design, unit operations both USP & DSP, and CIP/SIP. • Engage in Industry best practice forums such as BPOG, ISPE, PDA, ASME BPE, or CIP/SIP Summit to understand industry trends and represent Lonza as a technical leader to customers. Involved in driving evaluation of gaps with respect to standards, codes and regulations. • Mentor, coach, and support colleagues to solve complex problems and drive best-in-class design & functionality. • Strategic Project Assignments - Execute Engineering Projects functioning as Project Manager, Design Lead, and/or Commissioning Lead as assigned. Current Project - Large Scale Allogeneic Cell Therapy facility. Previous Project - New 2k high titer mammalian cell culture facility.

Education

• University of New Hampshire

  BS, Chemical Engineering

  2001 — 2005

Skills

• Cip Systems
• Capa
• Management
• Project Management
• Commissioning
• Corrective and Preventive Action (Capa)
• Cip
• U.s. Food and Drug Administration (Fda)
• Capital Projects
• Sip
• Biopharmaceuticals
• Change Control
• Purification
• Validation
• Gmp
• Cgmp
• Manufacturing
• Chromatography
• Engineering
• Ultrafiltration
• Technology Transfer
• Biotechnology
• Fda