Denny Mahfudin Email & Phone Number

Copenhagen, DK

Denmark

- Oversee the full system onboarding process, ensuring on-time and within-budget project delivery.- Establish and lead project teams to ensure effective collaboration and achievement of project goals.- Identify and implement new technologies to enhance system efficiency and performance.- Effectively communicate project status and updates to internal and.

Singapore

- Delivered comprehensive validation services to clients encompassing project management, commissioning, qualification, and validation of equipment, processes, and computer system validation (CSV). - Proficient in formulating project and equipment validation plans, conducting risk and impact assessments, executing qualification protocols, and generating.

Led management of the project and collaborate with clients and partners by providing strong technical expertise on process/product technologies to support selection, design, optimization, validation, and troubleshooting of pharmaceutical manufacturing processes and GMP-related activities.Responsible for close liaison with the management and key personnel.

Responsible for ensuring compliance of all qualification‐validation activities, including cleaning validation, aseptic process simulation, thermal mapping, distribution validation, and visual inspection qualification.- Planned qualification and validation schedule, led and coordinated with a team of 3 QA scientists on completing routine qualification and.

Managed teams on shop floor activities in the area of central service operations (media and buffer preparation, dispensing, equipment preparation, including cleaning and sterilization) and fill and finish area (formulation, filling, inspection, and secondary packaging)- Planned production schedule, led and coordinated with a team of 12 Production.

Key member of the project team for the establishment of a new GMP-certified biopharmaceutical facility with a total investment of US$ 35M. - Supervised cleanroom construction of production facilities which included advising on process layout design, machine installation, commissioning, and qualification.- Collaborated with the engineering and quality team.

Jakarta

• Involved in theoretical and hands-on training in the upstream and downstream process for the biopharmaceutical industry. - Perform wet lab activities and group projects using mammalian cell culture - Perform.
• Trained in the concept of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Quality Management System (QMS), and compliance with current regulatory standards.

Balikpapan

Increased the effectiveness of landfarming process in bioremediation facility plant up to 30% of TPH reduction by using slow-release fertilizers and appropriate bulking agents.