09/29/2026 updated
100 % available
Senior Technical Project Manager & WPO | Clean Utilities, Process Equipment, CQV & GMP
Frederikssund, Denmark
Worldwide
Chemical Engineering, Technical University of Denmark (DTU), 2015-2019About me
Chemical engineer and independent consultant focused on reliable delivery in GMP-regulated life science projects. I combine hands-on technical understanding with structured project leadership, clear stakeholder communication and strong ownership from design through operational handover.
Corrective and Preventive Action (CAPA)Project ManagementVerification and Validation (Software)Gmp-compliant DocumentationIndustrial Control - Commissioning
Chemical engineer and independent consultant with 7+ years of experience delivering GMP-regulated life science, pharmaceutical and medical-device projects. I work as Senior Technical Project Manager, Work Package Owner, Technical Lead and CQV/commissioning specialist, taking ownership from concept, Basic Design and Detailed Design through execution, qualification, system release, operational readiness and handover.
PROJECT & PACKAGE MANAGEMENT
• Technical project management and work-package ownership
• Scope, deliverables, milestones, dependencies, risk, quality and progress follow-up
• Cross-functional coordination across Engineering, QA, Production, Operations and external suppliers
• Supplier coordination, technical clarification, document review and follow-up
• Operational readiness, system release, turnover and handover to operations
CLEAN UTILITIES & PROCESS EQUIPMENT
• Purified water and GMP water systems
• HVAC and controlled production environments
• Nitrogen, compressed air and medicinal-oxygen systems
• Steam, cooling water, heating systems and glycol systems
• Ethanol systems and utility distribution
• Temperature Control Unit (TCU) systems
• Bioreactor equipment and other GMP-critical process equipment
• P&ID review, system boundaries, interfaces and technical documentation
CQV, COMMISSIONING & VALIDATION
• Risk-based CQV and commissioning under GMP and GEP
• Validation planning and qualification strategy
• User Requirements Specifications (URS)
• Design Qualification (DQ) and design review
• Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
• Installation Verification/Qualification (IV/IQ)
• Operational Verification/Qualification (OV/OQ)
• Performance Verification/Qualification (PV/PQ)
• Commissioning readiness, test documentation, punch-list follow-up and system handover
QUALITY, COMPLIANCE & DOCUMENTATION
• GMP/GEP compliance and quality-system interfaces
• CAPA, deviations and root-cause analysis
• Risk assessments and risk-based decision-making
• SOPs, protocols, reports and technical documentation
• Engineering-document review, traceability and QMS transfer
• Documentation readiness for commissioning, qualification and release
SELECTED DELIVERY RESULTS
• Coordinated transfer of more than 1,000 engineering documents into a client QMS
• Supported commissioning-documentation readiness and release activities for more than 15 utility systems
• Led CQV deliverables from design through handover
• Managed verification of a GMP-critical medicinal-oxygen air separation unit
Available for international freelance assignments in senior technical project/package management, clean utilities, process equipment, CQV, commissioning, validation, GMP documentation, supplier coordination, risk assessments and operational readiness.
Experience
Professional experience5 - 10 years
Freelancer since2025
Languages
DanishNative speakerEnglishFluent
Project history
CAPEX purification project, July 2025 - June 2026. Coordinated scope, progress, interfaces and delivery quality between client and suppliers across clean utilities. Reviewed component lists and P&IDs against scope, GMP requirements and documentation maturity. Coordinated transfer of more than 1,000 engineering documents into the client QMS. Supported commissioning and release of more than 15 systems, including cooling, steam, heating, nitrogen, ethanol and purified water. Facilitated GMP risk assessments and closure of technical actions for system release.
Certificates
Project Management Programme (IPMA-registered)
Mannaz2026