Reagent Technical Project Manager II

Biomerieux - Salt Lake City, UT

Full-time - Mid Level

Salt Lake City, UT

Merchant Wholesalers, Durable Goods

About the position

The Technical Project Manager II at bioMerieux SA is a pivotal role within the Reagent Manufacturing division, responsible for overseeing and managing projects that are critical to the manufacturing process. This position requires a collaborative approach, working closely with various leaders across operations, engineering, and continuous improvement teams, as well as other subject matter experts. The primary goal is to ensure that projects are executed on schedule and in compliance with design control and Quality Management System (QMS) requirements. In this role, the Technical Project Manager will be tasked with creating comprehensive project documentation, which includes project plans that outline the scope, resources, timelines, risks, and detailed phases of each project. The individual will also be responsible for developing and maintaining accurate project timelines and ensuring that all project management deliverables are met. This includes overseeing the implementation of new or improved manufacturing processes and equipment that add value to the Reagent Manufacturing and BMX operations. Regular communication is a key aspect of this role, as the Technical Project Manager will meet frequently with assigned project resources and provide updates to leaders and stakeholders within the organization. The position also involves monitoring project performance through periodic reporting and maintaining relevant quality documentation throughout the project lifecycle. The Technical Project Manager will apply project management best practices and promote Quality System Regulations (QSR) and regulatory compliance in all assigned projects. Additionally, the role requires the investigation and sharing of new methods and technologies to advance project goals, as well as conducting risk assessments and determining appropriate risk mitigations with the project team.

Responsibilities

• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System
• Lead Reagent projects with large scope and/or complexity throughout the project lifecycle
• Write project plans to document project scope, resources, timeline, risks, and detailed phases
• Create project management deliverables for assigned projects, including developing and maintaining accurate project timelines
• Oversee the implementation of new or improved manufacturing processes and equipment that deliver value to the Reagent Manufacturing and BMX
• Develop or oversee the creation of risk assessments, specifications, validation plans, protocols, and reports that support the qualification and validation of manufacturing processes
• Effectively lead project teams through identifying, creating, and tracking deliverables in a motivating and collaborative manner to drive the project to completion
• Schedule meetings, create agendas, circulate meeting minutes, facilitate project communications, and deliver presentations
• Monitor and communicate project performance through periodic reporting
• Create and maintain relevant quality documentation throughout the project
• Apply project management best practices throughout the project lifecycle
• Promote Quality System Regulations (QSR) and regulatory compliance into assigned projects
• Investigate, create, and share new methods and technologies for project advancement
• Effectively tailor project management best practices and processes to assigned projects based on context
• Conduct project risk assessments and determine risk mitigations and responses with the project team

Requirements

• Bachelor's degree in a related scientific field
• 2 years of project management experience
• 1 year of relevant industry experience
• Knowledge of validation strategies as they pertain to the medical device manufacturing industry
• Ability to relate with people at all levels within an organization
• Must work well independently as well as effectively in a team environment
• Must be able to work on multiple projects simultaneously
• Must be an effective and respectful communicator with project stakeholders
• Must be able to adapt to changes in projects and priorities with resilience

Nice-to-haves

• CAPM or PMP certifications
• 5 years of combined project management and relevant industry experience