Reagent Technical Project Manager II

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. 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 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

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

Training and Education

Required:

Bachelor’s degree related scientific field

Preferred:

CAPM or PMP certifications

Experience

Required:

2 years of project management experience

1 year of relevant industry experience

Preferred:

5 years of combined project management and 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