Role DescriptionThe successful candidate must have the discipline and technical knowledge to work independently and take on responsibilities as demanded by the projects. They must investigate and deploy innovative solutions to improve the efficiency of our current installations. They must ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.
They will work directly with Amgen SMEs, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met. The role will also require the generation of proposals for the 2019 program.
Responsibilities• Execute projects to Amgen Project Execution Plan (PEP) and meet all GMP requirements. • Ensure the highest levels of project safety. • Perform continual project risk analysis. • Identify project critical paths and prioritize accordingly. • Discover and understand end-user/process requirements; translate these into user requirements specifications. • Manage the compilation of all project documentation. • Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs. • Manage day to day project activities including permitting/method statement review etc. • Develop and document strong rational for testing strategy, acceptance criteria, and results. • Generate, review, and/or approve protocols, reports ensuring robust documentation for regulatory adherence. • Monitor installation quality and record inspections – Comply to Amgen and Dutch standards. • Set up and manage communication channels – Weekly report out/Project Team Meetings. • Follows a strict handover process to allow for future system maintenance. • Managing Key business stakeholders expectations/interactions (Planning, Manufacturing, Warehouse & Distribution, Customer Service and Quality). • Work with impacted functions to ensure alignment and operational readiness of new installations. • Manage resource & skills allocation and management of day-to-day activities.
Requirements• Project management qualification or 5+ years PM experience • MS Project • Cost/budget control • Change management • Excellent communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.