Process & Validation Engineering Leader | Biotechnology, Pharma & Specialty Chemical Systems | Complex Facility Design, Compliance & Technical Troubleshooting

Overview

Process engineering, project engineering, validation engineering, CAPA, commissioning, startup, remediation projects, P&IDs, utility systems, USP water systems, WFI systems, automation qualifications, HVAC systems, cleanrooms, CIP/SIP, bioreactors, lyophilizers, dose manufacturing, aseptic operations, mechanical engineering, pilot plant design, process safety management, cause and effect diagrams, Ishikawa diagrams, FMEA, HAZOP reviews, batch control systems, 21 CFR Part 11, water systems, filtration systems, chromatography, ultrafiltration, fermentation, media/buffer prep, aseptic processing, QMS/eQMS, change control, risk assessments, single-use systems, microelectronics processes, chemical plant operations, wastewater systems, ozonation systems, packaging systems, resin formulation, agricultural intermediates, energy recovery systems, infrastructure upgrades, nuclear-grade water, renewable electrification systems

Short Bio

Process, project, and validation engineering specialist with a long record of solving complex technical challenges across biotechnology, pharmaceuticals, chemicals, microelectronics, and food processing. Brings deep experience across process systems, utilities, commissioning, remediation, and compliance in highly regulated operations.

What I Bring

Broad multidisciplinary engineering expertise across biotech, pharma, food, chemical, and microelectronics
Strong ability to troubleshoot and resolve complex process and equipment issues
Extensive experience with utility systems, water systems, and critical manufacturing infrastructure
Proven success leading projects spanning design, commissioning, remediation, and validation
Deep knowledge of regulatory expectations, audit readiness, and consent decree environments
Ability to create clear, defensible engineering and validation documentation
Demonstrated capability managing full project life cycles from scoping to turnover

Key Technologies & Product Expertise

USP water, WFI, DI water, ASTM Type II systems
CIP/SIP systems
Bioreactors, lyophilizers, centrifuges
Filtration, ultrafiltration, diafiltration, chromatography systems
HVAC, cleanrooms, compressed gases, BMS systems
Ozonation systems, wastewater systems, energy recovery systems
Automation systems, batch control systems, 21 CFR Part 11 compliance
Aseptic filling, media formulation, buffer prep, protein manufacturing
Adhesives, coatings, agricultural intermediates, edible oils
Microelectronics process utilities

Titles Held

Process / Project / Validation Engineer, PROENGINEER (2002–Present)
Project Engineer / Manager, Pfizer/Wyeth/GSK (2001–2002)
Project Engineer / Manager, PROENGINEER (2000–2001)
Mechanical Engineer – Project Engineer / Manager, Emergent Biosolutions/BioPort (1999)
Project Engineer / Manager, PROENGINEER (1993–1998)
Process / Project Engineer – Manager, Marathon (AFRY/Jaakko Poyry) (1991–1992)
Plant Engineer – Manager, Rhodia/Rhone Poulenc (1989–1991)
Process / Mechanical Project Engineer – Manager, Lockwood Greene/Jacobs Engineering (1983–1989)
Facilities / Utilities Engineer, MEMC/Monsanto (1980–1982)
Process / Project Engineer, Dow/Union Carbide (1975–1980)

Career Highlights

Executed engineering, validation, and remediation work across more than 850 plants globally
Led major biotechnology and pharmaceutical projects including consent decree remediation and FDA audit preparation
Designed and validated complex systems including USP/WFI water, CIP/SIP, HVAC, BMS, automation, and controlled manufacturing environments
Managed multi-million-dollar utility, fermentation, and manufacturing system upgrades
Developed multiple ASO synthesis support systems and major URS documentation for large laboratory and biotech expansions
Delivered extensive work in microelectronics, chemical processing, nuclear-grade systems, and renewable electrification projects
Recognized for solving atypical process challenges across diverse technical environments
Contributed to community engineering education through mentoring, STEM engagement, and industry presentations

Education & Professional Certifications

International Studies, American University in Cairo (1987)
Chemical Engineering – Master’s, Marshall University / WV College of Graduate Studies (1976–1979)
MS Sanitary Engineering, Michigan State University (1974–1975)
BS Mechanical Engineering, Michigan State University (1969–1973)
Extensive professional development: 1,500+ PDH

Languages

English-Native

Impact

Delivered large-scale engineering, validation, and remediation programs that strengthened compliance and operational performance across biotechnology, pharmaceutical, chemical, and food manufacturing environments.
Solved complex, atypical engineering problems requiring multidisciplinary expertise, significantly improving system reliability, safety, and audit readiness.
Led high-impact projects involving process design, utility upgrades, safety improvements, and regulatory remediation, supporting successful inspections and commercial operations.
Drove technical clarity through comprehensive documentation, risk assessments, and system design, elevating organizational engineering standards.
Contributed to global industry advancement through work across more than 850 sites, informing best practices in system design, troubleshooting, and validation.