Jeff Morrell

About Jeff Morrell

Results-driven Expert Engineering Project Manager with experience leading projects in Pharmaceutical, Biotechnology, Medical Device, Consumer Products, and Petrochemical manufacturing industries—across both union and non-union environments. Adept at managing complex capital projects, optimizing manufacturing processes, and driving operational excellence in regulated environments.Key Expertise: • Project Leadership: Proven success in managing facility expansions, new product commercialization, process improvement initiatives, and equipment decommissioning. • Team Management: Experienced in leading and mentoring teams of up to 30 employees, including hourly, non-exempt, exempt, interns, and contractors in direct and matrixed organizations. • Capital Project Oversight: Skilled in managing budgets ranging from $1M to $30MM, ensuring cost control, efficiency, and ROI optimization. • Schedule & Resource Management: Expert in project scheduling, resource loading, and deadline management, ensuring timely and efficient project completion. • Engineering & Manufacturing Excellence: Extensive background in process development, project engineering, maintenance management, and product development across diverse manufacturing settings. • Commissioning, Qualification & Validation (CQV): Deep expertise in system and component classification, URS, DQ, IQ, OQ, temperature mapping, CSV, PQ, and process validation, particularly for automated manufacturing, packaging, and building systems in regulated industries.I thrive in fast-paced, highly regulated environments where I can leverage my expertise to drive efficiency, compliance, and innovation. Open to networking and opportunities to collaborate on impactful engineering and project management initiatives.

Experience

1. Program Manager

   Noramtec Consultants Inc.

   Sep 2022 — Present · Bloomington, IN, US

   Program manager for EN ISO 11607-1:2020+A1:2023 and EN ISO 11607-2:2020+A1:2023 design and process validation alignment, process monitoring infrastructure, and new technology validation for a world-renowned medical device manufacturer (Cook Medical).• Serve as EN ISO 11607-2:2020+A1:2023 sterile barrier process validation technical expert in the application of notified body interpretation of the standard as it applies to EUMDR standards.• Serve as capital project manager for new entity standard tray sterile barrier sealers with multiple tray sizes.• Create, update, and report on project schedules for more than 100 individual sterile barrier packaging projects including existing sealer validation remediation, new technology sealer validation, process monitoring infrastructure, and individual product sterile barrier submittal documentation.• Develop and implement program strategy.• Develop program prioritization tool to improve critical deliverable delivery throughout the packaging program.

Education

• Kansas State University

  BS, Chemical Engineering

  1991 — 1995

• The University of Kansas

  Master's of Engineering Management - Not Complete, Engineering/Industrial Management

  2003 — 2004

Skills

• Computer System Validation
• Project Engineering
• Change Management
• Project Planning
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Standard Operating Procedure (Sop)
• Process Validation
• Testing
• Quality Assurance
• Capital Projects
• Change Control
• Comissioning
• Engineering
• Staff Supervision
• Corrective and Preventive Action (Capa)
• Cross-Functional Team Leadership
• Packaging
• Iso 13485
• Commissioning
• Process Engineering
• Calibration
• Engineering Management
• Pharmaceuticals
• Lean Manufacturing
• Root Cause Analysis
• Verification and Validation (V&V)
• Project Management
• Process Scheduler
• Automation
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Maintenance Management
• Fda
• Fmea
• Validation
• Continuous Improvement
• Qualification
• Process Improvement