Due to the success of PETra, our market leading LIMS software for radiopharmaceutical production, we are currently seeking a new support person to join our team. The ideal candidate will have a background in PET production and be familiar with FDA regulatory compliance. This is a customer facing role with a high level of interaction to advise on numerous technical aspects with respect to implementation, processes, and applications.
As a Project Manager, you will oversee projects for our market leading nuclear medicine LIMS (Laboratory Information Management System), PETra. The role involves frequent travel to our customer sites mostly in North America, but also some international travel is expected. The on-site visits will focus on customer training, system deployment and validation of our LIMS software program.
- Own and lead the end-to-end validation lifecycle including Validation Planning, IQ, OQ and support of PQ activities while ensuring compliance with regulatory standards
- Manage and prioritise multiple ongoing projects and customer needs, ensuring successful delivery, timelines and stakeholder satisfaction
- Deliver customer training and enhance training materials to support both basic and advanced use of the LIMS software
- Provide post-installation support including helpdesk assistance, troubleshooting and ongoing customer guidance
- Test and approve software updates, taking ownership of customer upgrades including on-site validation and system testing where required
- Support business development activities by delivering software demonstrations to prospective customers and assisting the sales process
Essential
- Experience working with radiopharmaceutical production and quality control processes.
- Understanding of FDA regulations and GMP.
- Ability to work with the internal software development and QA teams to help drive future developments.
- Experience working with synthesis modules, chromatography software, and other production and quality control equipment.
Desirable
- Experience writing technical documents such as SOPs or change controls and working with QMS systems.
- Basic knowledge of programming structure.
- Experience working with end users on-site to ensure successful deployments, training, and customer satisfaction.
- Experience working with IT teams at customer facilities.
We offer outstanding benefits such as an auto allowance, 401(k) with match, comprehensive medical, dental, and vision insurance, and a generous allotment of 21 days of paid vacation, in addition to company holidays.
With an expanding organization, there are substantial growth opportunities for high performers.
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