Global Strategic Experience
24 years of global business system ownership across pharmaceutical manufacturing operations
Enterprise System Leadership
Extensive experience in global business system ownership, managing enterprise-wide deployments of critical manufacturing systems across multiple pharmaceutical production sites. Proven track record in defining strategic roadmaps, establishing governance frameworks, and driving digital transformation initiatives in GxP-regulated environments.
SAP Plant Maintenance (PM)
Super User - DuPont de Nemours & Novartis Sites
Multi-Site SAP PM Implementation
Led comprehensive SAP Plant Maintenance module implementation across DuPont de Nemours and Novartis pharmaceutical production sites, establishing standardized maintenance management systems aligned with GxP requirements and asset reliability strategies.
DuPont de Nemours Implementation
- Integration with existing ERP and asset management systems
- Preventive maintenance program digitalization
- Spare parts inventory optimization in MM module
- Work order management and CMMS workflow automation
Novartis Pharmaceutical Sites
- GxP-compliant maintenance management implementation
- Critical equipment prioritization (ABC classification)
- Regulatory compliance documentation automation
Functional Location (FLOC) Structure Design
Developed comprehensive functional location hierarchies based on ISO 14224 and industry best practices, establishing logical asset organization from plant level down to individual components.
FLOC Hierarchy Implementation
- Level 1 - Site/Plant: Top-level organizational structure (e.g., SITE-BASEL)
- Level 2 - Production Area: Manufacturing zones and buildings (e.g., PROD-BUILDING-A)
- Level 3 - Process Unit: Functional production units (e.g., FORMULATION-LINE-01)
- Level 4 - System: Functional systems within units (e.g., HVAC-SYSTEM-01)
- Level 5 - Equipment Group: Logical equipment groupings (e.g., REACTOR-GROUP-01)
- Level 6 - Component: Individual maintainable items (e.g., PUMP-001-A)
FLOC Design Principles
- Process-oriented hierarchy aligned with P&IDs
- Standardized naming conventions across sites
- Integration with engineering documentation
- Support for cost center allocation and reporting
- Scalability for future expansions and modifications
Master Data Management
- FLOC master record creation and maintenance
- Classification system development (CLASS/CHARACTERISTICS)
- Technical object linking (equipment, BOM, documents)
- Planning plant and maintenance plant assignments
- ABC indicator and criticality classification
Maintenance Planning & Strategy
Developed comprehensive maintenance planning framework encompassing preventive, predictive, and corrective maintenance strategies with automated work order generation and scheduling optimization.
Maintenance Plans & Task Lists
- Time-based and performance-based maintenance plans
- Multi-level maintenance task lists and operations
- Material/spare parts requirements per operation
Work Order & Analytics
- Automatic work order generation and scheduling
- Equipment downtime and MTBF/MTTR analysis
- Regulatory compliance reporting and audit trails
AVEVA PI System
Global Business System Owner
Global Deployment & System Ownership
Led enterprise-wide implementation and management of AVEVA PI System as the centralized real-time data infrastructure platform across multiple pharmaceutical production sites globally.
Platform Architecture
- Global PI Server infrastructure deployment
- PI Data Archive configuration and management
- PI Asset Framework (AF) implementation
- PI Vision dashboards for real-time visualization
- PI Interface configuration for multiple data sources
Multi-Site Deployment
- Standardized global architecture design
- Site-specific implementation across production facilities
- Data integration from DCS, SCADA, and PLC systems
- Global data replication and centralization
- Enterprise-wide data governance framework
Business System Ownership Responsibilities
- Global strategy and roadmap development for PI System evolution
- Cross-functional stakeholder management (Operations, IT, Engineering, Quality)
- Budget planning and resource allocation for global deployments
- Vendor relationship management with AVEVA/OSIsoft
- Platform upgrade planning and execution across all sites
- Best practice development and knowledge sharing across regions
- Performance monitoring and system optimization
- Compliance and validation coordination for GxP environments
HighByte Intelligence Hub
Global Business System Owner
Global Deployment & System Ownership
Established global business system ownership for HighByte Intelligence Hub platform, managing deployment across multiple pharmaceutical manufacturing sites to enable industrial DataOps and seamless data integration from OT to IT systems.
System Capabilities
- Industrial DataOps platform for OT/IT integration
- Unified Namespace (UNS) architecture implementation - enabling AI/ML model training, LLM integration, and intelligent analytics through standardized, contextualized industrial data streams
- Real-time data modeling and contextualization for AI-ready datasets
- No-code data transformation and normalization
- Multi-protocol connectivity (OPC UA, MQTT, Modbus, etc.)
- Secure data delivery to cloud, historians, and analytics platforms
Multi-Site Implementation
- Global standardization of data integration patterns
- Site-specific equipment and process data modeling
- Centralized data pipeline management
- Cross-site data harmonization and analytics enablement
- Edge-to-cloud architecture deployment
Business System Ownership Responsibilities
- Global DataOps strategy aligned with digital transformation initiatives
- Standardized data integration architecture across all sites
- Data governance and quality management framework
- Global deployment standards and best practices
- Vendor partnership management and technical collaboration
- Platform performance monitoring and optimization
- Integration roadmap with MES, ERP, historians, and analytics platforms
- Security and compliance framework for industrial data pipelines
MES Koerber PAS-X
Shopfloor Integration Consultant
MES Integration & Shopfloor Connectivity
Led comprehensive integration of Koerber PAS-X MES with shopfloor equipment and systems, establishing seamless data exchange between manufacturing execution and production equipment across pharmaceutical operations.
MES-Equipment Integration
- MSI (message-based shopfloor integration) protocol implementation
- Bidirectional data exchange with production equipment
- Electronic batch record integration with DCS/SCADA systems
- Material tracking and genealogy from equipment to MES
MSI Protocol & Interface Functions
- Recipe download from MES to equipment controllers
- Process values and parameters upload to MES
- Equipment state management (idle, running, complete, error)
- Critical product parameter Alarms and events integration
Shopfloor System Architecture
Connected Systems
- PLC/DCS controllers (Siemens, Rockwell, ABB)
- SCADA systems for process visualization
- Weighing and dispensing equipment
- Packaging line controllers and vision systems
- Laboratory instruments and analytical equipment
Integration Technologies
- OPC UA/DA for standard equipment connectivity
- Custom MSI adapters for legacy systems
- REST APIs for modern equipment integration
- Database triggers for indirect data exchange
- Message queuing for reliable transaction handling
Key Achievements & Capabilities
- Implemented paperless manufacturing with electronic batch records synchronized to equipment
- Automated data transfer of order information, variable data, and recipes to production equipment with seamless synchronization
- Validated interfaces ensuring data integrity across MES-equipment boundary
KNEAT Validation Lifecycle Management
Super User for eC&Q - Global Automation
Super User Expertise & Global Automation
Served as KNEAT super user with deep expertise in electronic commissioning and qualification (eC&Q) processes, driving automation initiatives for global validation lifecycle management across pharmaceutical operations.
eC&Q Platform Expertise
- Digital validation protocol development and execution
- Automated test script creation and management
- Electronic workflow configuration and optimization
- Digital signature and 21 CFR Part 11 compliance
- Automated report generation and deviation management
Global Automation Initiatives
- Template standardization across global sites
- Automated IQ/OQ/PQ protocol generation
- Integration with enterprise quality systems
- Data migration from paper-based to digital validation
- Cross-site collaboration and knowledge sharing
Super User Responsibilities
- Advanced system configuration and customization for complex validation scenarios
- Power user training and mentoring for global validation teams
- Best practice development for digital validation workflows
- Technical support escalation and issue resolution
- System enhancement recommendations and feature requests
- Validation efficiency metrics tracking and optimization
- Cross-functional collaboration with Quality, Engineering, and IT
- Regulatory compliance guidance for computerized systems validation
Impact & Achievements
- Reduced validation cycle time by 40% through automation
- Established paperless validation processes across sites
- Improved data integrity and audit trail completeness
- Enhanced cross-site validation consistency and compliance
- Enabled real-time validation status tracking and reporting
- Facilitated faster regulatory inspection readiness
Computer System Validation (CSV) Consultant
Enterprise & Site CSV - Global SOP Development
Global CSV SOP Framework Development
Led enterprise-wide and site-level Computer System Validation (CSV) standardization initiatives, developing comprehensive global Standard Operating Procedures (SOPs) for commissioning and qualification (C&Q) activities across pharmaceutical manufacturing operations to ensure GxP compliance and regulatory readiness.
Global CSV SOP Development
- Enterprise-level CSV policy and governance framework
- Standardized validation lifecycle procedures (GAMP 5 aligned)
- Risk-based approach to system categorization and validation
- Global SOP templates for IQ/OQ/PQ documentation
- Change control and periodic review procedures for validated systems
- Data integrity controls aligned with ALCOA+ principles
Commissioning & Qualification SOPs
- Standardized C&Q protocols across global manufacturing sites
- Equipment qualification procedures (DQ/IQ/OQ/PQ)
- Process validation master plans and execution protocols
- Utility system qualification (water, HVAC, clean steam)
- Facility qualification and environmental monitoring
- Cleaning validation and product changeover procedures
Regulatory Compliance & System Categories
Regulatory Framework
- 21 CFR Part 11 electronic records and signatures compliance
- EU Annex 11 computerized systems validation
- GAMP 5 risk-based validation methodology
- FDA/EMA inspection readiness and documentation
- PIC/S guidance for computerized systems
System Categories Covered
- Manufacturing Execution Systems (MES)
- Laboratory Information Management Systems (LIMS)
- Enterprise Resource Planning (ERP/SAP)
- Distributed Control Systems (DCS/SCADA)
- Electronic Batch Records (EBR) systems
- Quality Management Systems (QMS)
CSV Consulting Services & Deliverables
- Site-specific CSV implementation roadmaps and gap assessments
- Validation Master Plan (VMP) development and maintenance
- User Requirements Specification (URS) and functional requirements
- Supplier assessment and vendor audit support for GAMP category systems
- Traceability matrix development (URS to test protocols)
- Validation summary reports and regulatory submission packages
- Training programs for site personnel on CSV and C&Q procedures
- Post-implementation periodic review and system retirement procedures
- Global harmonization of validation practices across manufacturing network
- Deviation investigation and CAPA for validation non-conformances
SCADA Systems
Global Lead - Pharmaceutical Manufacturing
SCADA Global Leadership & Standards
Led global SCADA strategy and implementation for key production equipment and systems across pharmaceutical manufacturing operations, establishing standardized automation user requirements and enabling comprehensive use case development.
Key Production Equipment Integration
- Batch reactors and fermentation systems
- Formulation and mixing equipment
- Filling and packaging lines
- Utilities and environmental control systems (HVAC, clean steam, WFI)
- CIP/SIP (Clean-in-Place/Sterilize-in-Place) systems
Standard Automation Requirements
- Unified HMI/SCADA visualization standards
- Alarm management and prioritization framework
- Batch control and recipe management
- Process data historian integration
- GxP compliance and 21 CFR Part 11 requirements
Use Case Enablement
Defined standardized automation user requirements to enable multiple operational use cases across the manufacturing lifecycle:
Operational Use Cases
- Real-time production monitoring and KPI visualization
- Equipment performance tracking (OEE, availability, quality)
- Process deviation detection and notification
- Predictive maintenance based on process parameters
- Energy consumption monitoring and optimization
Quality & Compliance Use Cases
- Electronic batch record integration and review
- Critical process parameter (CPP) monitoring
- Audit trail and data integrity assurance
- Regulatory reporting and trending analysis
- Out-of-specification (OOS) investigation support
System Integration Architecture
Established comprehensive qualification strategies for SCADA interfaces with enterprise manufacturing systems:
Critical System Interfaces
- MES Integration: Bidirectional data exchange for production orders, material tracking, and batch execution
- Site Recipe Management: Recipe download to SCADA, version control, and parameter synchronization
- Domain Controller: User authentication, role-based access control (RBAC), and security policy enforcement
- Historian Systems: Real-time process data collection, compression, and long-term archival
Interface Qualification Strategy
- Interface design specifications (IDS) documentation
- Data mapping and transformation validation
- Protocol testing (OPC UA/DA, MQTT, Modbus, REST APIs)
- Error handling and failover scenario testing
- Performance and load testing
GxP Qualification Approach
- Risk-based qualification strategy (GAMP 5 principles)
- Factory Acceptance Testing (FAT) protocols
- Site Acceptance Testing (SAT) execution
- Integration Qualification (IQ) for interface components
- Operational Qualification (OQ) for end-to-end workflows
Global Standards & Governance
Technical Standards
- ISA-88 (Batch Control) and ISA-95 (Enterprise-Control Integration)
- Standardized naming conventions and tag structures
- Cybersecurity architecture (IEC 62443, network segmentation)
- Backup, disaster recovery, and business continuity
Global Governance Framework
- Change control procedures and impact assessment
- Configuration management and version control
- Training and competency management for operators
- Continuous improvement and lessons learned programs
Pharmaceutical Equipment Standardization Program
Participated as key member of enterprise-wide equipment standardization program, collaborating with major pharmaceutical manufacturing equipment vendors to establish unified automation requirements and SCADA integration standards across the global manufacturing network.
Key Manufacturing Equipment Players
- GEA: Tablet coating, granulation, and solid dose processing equipment
- Bosch: Filling and packaging line automation systems
- Syntegon (formerly Bosch Packaging): Blister packaging and cartoning systems
- Fette Compacting: Tablet press automation and control systems
- Körber (Dividella, Medipak): Secondary packaging automation
- IMA Group: Integrated processing and packaging solutions
Automation Standardization Objectives
- Unified HMI/SCADA design standards across all equipment suppliers
- Standardized PLC programming practices and function blocks
- Common data models and tag naming conventions (ISA-88/95 aligned)
- Consistent alarm management and event handling
- Harmonized equipment-to-MES interface specifications
- Common OPC UA server implementation for data connectivity
Program Deliverables & Impact
- Enterprise User Requirements Specification (URS) for automation and SCADA systems
- Vendor automation design standards and compliance matrix
- Standardized Factory Acceptance Testing (FAT) protocols for equipment qualification
- Reduced operator training requirements through consistent HMI/SCADA interfaces
- Accelerated equipment commissioning and validation timelines
- Enhanced data interoperability across multi-vendor manufacturing environments
- Improved spare parts management and maintenance efficiency
- Enabled global manufacturing network scalability and equipment replication
Site Recipe Management System (SRMS)
Global Business System Owner
Global Business System Ownership
Established and maintained global business system ownership for the Site Recipe Management System (SRMS), providing centralized recipe governance, version control, and distribution capabilities across the pharmaceutical manufacturing network to ensure production consistency, compliance, and operational efficiency.
Core SRMS Capabilities
- Centralized recipe repository with version control and audit trail
- Multi-level recipe hierarchy (master, site, equipment-specific)
- Electronic recipe approval workflow with role-based authorization
- Recipe distribution to production equipment (DCS, SCADA, PLC)
- Real-time recipe synchronization across global manufacturing sites
- Recipe parameter change management with impact assessment
- Integration with MES for production order recipe assignment
Recipe Lifecycle Management
- Recipe creation and development workflow
- Recipe validation and testing protocols
- Version control with full historical traceability
- Recipe activation, deactivation, and retirement processes
- Recipe comparison and deviation analysis tools
- Mass recipe updates and global rollout coordination
- Recipe migration between development, test, and production environments
System Integration & Technology
Integration Architecture
- MES Integration: Recipe download requests, production order linkage, batch record integration
- SCADA/DCS Systems: Automated recipe download, parameter mapping, real-time synchronization
- PLM/Product Development: Recipe transfer from R&D to manufacturing
- Quality Systems: Recipe specification verification, quality parameter validation
- ERP/SAP: Material master data linkage, BOM integration
Technology Stack
- ISA-88 (S88) batch control standard compliance
- OPC UA/DA for equipment connectivity
- XML/JSON-based recipe data exchange formats
- REST APIs for system-to-system integration
- Database replication for multi-site deployment
- Electronic signature integration (21 CFR Part 11)
GxP Compliance & Data Integrity
Regulatory Compliance
- 21 CFR Part 11 electronic records and signatures
- EU GMP Annex 11 computerized systems validation
- Complete audit trail for all recipe changes and approvals
- Role-based access control and user authentication
- Data integrity controls (ALCOA+ principles)
Validation & Qualification
- CSV (Computer System Validation) execution
- IQ/OQ/PQ protocol development and execution
- Risk-based validation approach (GAMP 5)
- Change control and periodic review procedures
- Disaster recovery and business continuity testing
Business System Owner Responsibilities
- Global SRMS strategy and roadmap aligned with manufacturing digital transformation
- Standardized recipe data models and naming conventions across all sites
- Governance framework for recipe creation, approval, and distribution
- Global deployment coordination and multi-site implementation oversight
- Vendor relationship management and system enhancement prioritization
- User training programs and competency management for recipe administrators
- Performance monitoring, system optimization, and capacity planning
- Integration roadmap with MES, SCADA, ERP, and quality systems
- Regulatory compliance oversight and audit support
- Cross-functional stakeholder management (Manufacturing, Quality, Engineering, IT)
- Global recipe standardization initiatives and best practice sharing
Pharmaceutical Serialization & Track-and-Trace
Global Automation Lead - Sales Pack Serialization & Security Features
Global Track-and-Trace Implementation Leadership
Led global implementation of pharmaceutical serialization and track-and-trace solutions for sales pack identification, establishing comprehensive anti-counterfeiting measures and regulatory compliance frameworks across worldwide manufacturing operations and CMO partnerships.
Serialization Technology Deployment
- Sales pack (secondary packaging) serialization systems
- Aggregation of serialized units to cases and pallets
- 2D Data Matrix barcode printing and verification
- Vision inspection systems for code quality assurance
- Line integration with existing packaging equipment
Security & Anti-Counterfeiting Features
- Unique serial number generation and management
- Tamper-evident seals and security labels
- Covert and overt authentication features
- Product verification and authentication capabilities
- Supply chain integrity monitoring
Regulatory Evolution & Global Compliance
Navigated complex regulatory landscape from early pedigree requirements through modern global serialization mandates:
Regulatory Timeline & Milestones
- 2006 - California Pedigree Law: Early implementation of electronic pedigree tracking, establishing foundational serialization capabilities and supplier qualification processes
- France - 2D Data Matrix Implementation: Pioneered deployment of GS1 2D Data Matrix codes on pharmaceutical packaging, setting precedent for European markets
- EU FMD (Falsified Medicines Directive): Full compliance with safety features and unique identifier requirements across European operations
- US DSCSA (Drug Supply Chain Security Act): Implementation of serialization and interoperable electronic data exchange
- Global Market Compliance: Adaptation to country-specific requirements (Turkey TITS, South Korea, China, Brazil, India, Russia, Saudi Arabia, etc.)
Regulatory Requirements Management
- GS1 standards compliance (GTIN, GLN, SSCC)
- Country-specific data element requirements (GTIN, serial, lot, expiry)
- National repository connectivity and reporting
- Mass serialization vs. randomized approaches
- Aggregation level requirements (unit, case, pallet)
Compliance Documentation
- Validation documentation for serialization systems
- Data integrity and audit trail requirements
- Change control for regulatory updates
- Supplier quality agreements and assessments
- Regulatory filing and submission support
Global Supplier Selection & Standardization
Defined and implemented standardized global track-and-trace solution with comprehensive supplier qualification and technology selection:
Supplier Qualification Process
- Global RFP process for track-and-trace platform selection
- Technical capability assessment and proof-of-concept
- Regulatory compliance coverage evaluation
- Scalability and performance benchmarking
- Total cost of ownership (TCO) analysis
- Vendor financial stability and long-term viability
Technology Platform Standardization
- Enterprise-level track-and-trace management system
- Central serial number repository and management
- Multi-site deployment architecture
- Integration with ERP (SAP) and MES systems
- National repository connectivity middleware
- Global reporting and analytics dashboard
CMO (Contract Manufacturing Organization) Compliance
Established comprehensive framework ensuring worldwide CMO partners comply with identical serialization user requirements and quality standards:
CMO User Requirements
- Standardized serialization technical specifications
- Data format and communication protocol requirements
- Aggregation and parent-child relationship rules
- Exception handling and line clearance procedures
- Quality control and verification processes
- System qualification and validation expectations
CMO Quality Assurance
- Serialization system capability assessments
- Regular audit and inspection programs
- Data integrity and traceability verification
- Performance metrics and KPI monitoring (yield, uptime)
- Incident management and CAPA processes
- Technology refresh and upgrade requirements
Global CMO Network Management
- Consistent user requirement specifications across 50+ CMO sites worldwide
- Serial number allocation and management for external manufacturers
- Secure data exchange protocols and connectivity standards
- Training and knowledge transfer programs for CMO personnel
- Change management coordination for regulatory updates
- Harmonized quality agreements and service level expectations
Implementation & Technical Architecture
Line Integration & Automation
- Packaging line PLC/SCADA integration
- Print-and-verify station deployment
- Vision system integration for quality verification
- Line controller communication (OPC UA, REST APIs)
- Reject and quarantine automation
- Line performance optimization (minimal impact on OEE)
Enterprise Integration Architecture
- SAP ERP integration (material master, production orders)
- MES integration for production execution data
- Quality management system (QMS) connectivity
- Warehouse management system (WMS) integration
- National/regional repository connections (NMVS, DSCSA)
- Business intelligence and analytics platforms