Organon — Industrial Automation & Life Cycle Management
Technical Project Manager | Industrial Automation & GMP Compliance
February 2022 – August 2022
Led the upgrade of a Environmental Monitoring System within a regulated pharmaceutical manufacturing environment.
Responsible for establishing structure and execution control across a multidisciplinary project team covering engineering, software, quality, suppliers and business stakeholders, including testing, validation and documentation in accordance with GMP and GAMP 5 principles.
Key responsibilities & contributions
- Setting up and leading the EMS upgrade from scope definition and planning through engineering, testing, validation, implementation and operational handover
- Coordinating software development, testing and validation activities, including GMP/GAMP 5 documentation and qualification deliverables such as IQ/OQ and related quality documentation
- Managing project scope, priorities, planning, risks and execution
- Coordinating SCADA / iFix software development, engineering and validation activities
- Aligning engineering, operations, quality, suppliers and business stakeholders
- Managing technical interfaces, dependencies and project deliverables
- Coordinating procurement activities and supplier contributions
- Driving structured issue resolution, implementation and handover
- Ensuring alignment with GMP and GAMP 5 validation and documentation requirements
Environment & expertise
- Pharmaceutical manufacturing
- Environmental Monitoring System (EMS)
- SCADA / iFix
- Industrial automation & OT
- GMP / GAMP 5 validation
- Technical project management
- Engineering coordination & stakeholder management
- Supplier management
- Testing, validation & operational handover
