Technical Project Manager

Client

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

Master degree in (Biomedical) Engineering or a related technical field with more than 5 years of demonstrated experience in project management and Annex 1implementation.
Demonstrable and extensive knowledge of one or more of the following: GMP cleanroom design, isolators, filling and dispensing systems, non-viable monitoring,(semi-) automated visual inspection.
Solid understanding of regulatory requirements and GMP guidelines.
Risk assessment and technical report writing skills.
Excellent communication and coordination skills in Dutch and English.

Own several projects related to Annex 1 and upgrading future capabilities.
Interact and coordinate externally with manufacturers and internally with the Annex 1 project lead, senior management, sponsor contacts to establish and maintain a steady progress in the projects.
Act as the primary point of contact for on-going Annex 1 projects, performs risk assessments, monitors technical performance, documents existing and required capabilities.
Act as an SME in the risk assessments to identify site risks and drafts mitigation action plans.
Coordinate and provide expertise during commissioning of the equipment, cleanroom redesign or process changes as per established plan requirements.