Project Coordinator- Radiopharmacy (PETra)

Job Description

The Company

LabLogic Systems is a leading supplier and manufacturer of instrumentation and software to the pharmaceutical, nuclear medicine and radiation safety sectors. We have over 40 years’ experience and expertise in providing solutions within highly regulated environments. Many of LabLogic’s solutions are the industry standard and can be found in over 50 countries around the world. Our products enjoy the highest reputation for providing compliance, reliability and ease of use.

We're committed to excellence, delivering high-quality products and service while fostering a positive work culture grounded in our core values: Passionate and driven, Everyone is accountable, Respectful and inclusive, Family atmosphere, Efficient, Customer-focused, and Trustworthy. Recently, the LabLogic Group was honoured with the prestigious King’s Award for Enterprise in International Trade and achieved the Investors In People Gold accreditation, affirming our commitment to creating an exceptional workplace.

This role, when not travelling, will be based remotely.

The Role

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.

Responsibilities

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• 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
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• Manage and prioritise multiple ongoing projects and customer needs, ensuring successful delivery, timelines and stakeholder satisfaction
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• Deliver customer training and enhance training materials to support both basic and advanced use of the LIMS software
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• Provide post-installation support including helpdesk assistance, troubleshooting and ongoing customer guidance
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• Test and approve software updates, taking ownership of customer upgrades including on-site validation and system testing where required
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• Support business development activities by delivering software demonstrations to prospective customers and assisting the sales process
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Requirements

Essential

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• Experience working with radiopharmaceutical production and quality control processes.
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• Understanding of FDA regulations and GMP.
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• Ability to work with the internal software development and QA teams to help drive future developments.
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• Experience working with synthesis modules, chromatography software, and other production and quality control equipment.
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Desirable

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• Experience writing technical documents such as SOPs or change controls and working with QMS systems.
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• Basic knowledge of programming structure.
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• Experience working with end users on-site to ensure successful deployments, training, and customer satisfaction.
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• Experience working with IT teams at customer facilities.
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Benefits

This position offers a salary range of $80,000-$100,000 per year, depending on skills, experience, qualifications, and overall fit for the role. In addition, we offer an excellent benefits package including a 401(k) with company match, comprehensive medical, dental, and vision insurance, and 21 days of paid vacation annually, in addition to company holidays.

With an expanding organization, there are substantial growth opportunities for high performers.