Description

bioMérieux currently has Project Manager openings in the Technology Transfer department on the following team:

• Manufacturing & Automation. Project managers on this team work closely with our engineers, reagent manufacturing team, and program managers leading change control and project management activities related to improvements to and automation of manufacturing equipment.

At BioFire, Technology Transfer Project Managers work with the most innovative and dedicated scientists and engineers in the medical device industry!

Project Managers on all Technology Transfer teams facilitate the transfer, sustainment, and improvement of products and processes from research and development to a final product ready to send to customers. They ensure changes are documented and maintained according to regulatory standards and quality system requirements. They do this by collaborating cross-functionally to ensure that all changes are properly understood and documented appropriately within the guidelines of BioFire Diagnostics' quality management system (QMS).

Primary responsibilities include:

• Lead and monitor multiple projects throughout the project lifecycle
• Write, revise, and present change notifications, change orders, protocols and reports, work instruction documents, standard operating procedures, qualifications, product specifications, and verification and validation plans
• Develop and maintain timelines, schedule meetings, create agendas and presentations, facilitate discussions, and document meeting minutes and action items
• Adhere to BioFire's Change Control Process and Quality Management System to identify the associated impact, risk, and testing
• Collaborate with other departments and stakeholders to ensure transfer projects and activities are scoped and completed on schedule

The ideal candidate must have:

• Bachelor's degree in relevant scientific or engineering field. Significant related experience may be considered in lieu of degree.

Project Manager I

• 3 years of relevant work experience
• 3 or more years of experience in ISO 900, 13485 and/or cGMP/cGLP compliant environments, including manufacturing, medical device, or regulated environments, are preferred
• 2 years of project management or related experience
• Relevant MBA and/or PMP certification from Project Management Institute a plus

Project Manager II

• 6 years of relevant work experience
• 3 or more years of experience in ISO 900, 13485 and/or cGMP/cGLP compliant environments, including manufacturing, medical device, or regulated environments, are preferred
• 3 years of project management or related experience
• Relevant MBA and/or PMP certification from Project Management Institute a plus

• Ability to work in a fast-paced and dynamic environment
• Strong analytical and problem-solving skills
• Excellent communication skills - verbal, written, and presentation