BioFire Diagnostics
Reagent Technical Project Manager III
BioFire Diagnostics, Salt Lake City, Utah, United States, 84193
Technical Project Manager
This position is located in Salt Lake City, Utah and would be expected to report onsite at this location. The Technical Project Manager is assigned to projects within Reagent Manufacturing. This individual will collaborate with various leaders within manufacturing including operations, engineering, continuous improvement and other subject matter experts to create project documentation and implement projects on schedule as well as within accordance with design control and QMS requirements. In addition to meeting regularly with assigned project resources, this individual is also expected to provide regular project updates to leaders and stakeholders within the organization. Primary Duties Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System Lead Reagent projects with significant scope, scale, and 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 Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways 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 Lead projects that may require overseeing the execution of sub-projects led by other project managers May mentor, lead, and train other Reagent Project Managers Education and Experience Bachelor's degree related scientific field CAPM or PMP certification 5 years of project management experience 2 years of relevant industry experience Knowledge, Skills, and Abilities 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 Ability to manage cross-functional projects and effectively engage with many types of stakeholders, internal and external to Reagent Manufacturing BioMrieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMrieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).
This position is located in Salt Lake City, Utah and would be expected to report onsite at this location. The Technical Project Manager is assigned to projects within Reagent Manufacturing. This individual will collaborate with various leaders within manufacturing including operations, engineering, continuous improvement and other subject matter experts to create project documentation and implement projects on schedule as well as within accordance with design control and QMS requirements. In addition to meeting regularly with assigned project resources, this individual is also expected to provide regular project updates to leaders and stakeholders within the organization. Primary Duties Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System Lead Reagent projects with significant scope, scale, and 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 Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways 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 Lead projects that may require overseeing the execution of sub-projects led by other project managers May mentor, lead, and train other Reagent Project Managers Education and Experience Bachelor's degree related scientific field CAPM or PMP certification 5 years of project management experience 2 years of relevant industry experience Knowledge, Skills, and Abilities 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 Ability to manage cross-functional projects and effectively engage with many types of stakeholders, internal and external to Reagent Manufacturing BioMrieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMrieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).