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Position Summary

Implements and administers multiple projects of low to medium complexity, each potentially consisting of sub-projects. Organizes cross-functional activities to ensure project completion while adhering to regulations, scope, and schedule requirements. Acts as an in-house consultant for project evaluation needs. Plans and directs implementation efforts, evaluating the scope and impact of new products and processes, and providing feedback on proposed changes.

Primary Duties

• Ensures all work complies with company policy and adheres to bioMerieux’s Quality System guidelines.

• Coordinates efforts for the transfer (industrialization) of instrument products and/or manufacturing equipment from R&D to Instrument Manufacturing.

• Lead and monitor projects, applying best practices throughout initiation, planning, development, implementation, and launch. Ensure projects meet quality, scope, and schedule objectives while maintaining regulatory standards and quality system requirements.

• Plan and direct cross-functional change implementation, including evaluating impact, risks, and scope for new and existing products and processes.

• Act as the point of contact and transfer expert for assigned projects. Provide technical support and improvements to existing products and processes.

• Ensure consistent practices are maintained throughout all phases of the project life cycle.

• Schedule meetings, create agendas, and document meeting minutes, correspondence, and presentations.

• Develop, establish, and maintain accurate project timelines.

• Coordinate updates to manufacturing process documents, including Standard Operating Procedures, Batch Records, risk assessments, specification documents, and drawings.

• Communicate, prepare, and present reports, summaries, and analyses to support project status and progress.

• Create and maintain relevant project documentation throughout the project lifecycle.

• Execute high-quality, integrated, cross-functional plans for projects.

• Interact with and coordinate activities between Engineering R&D, Program Management, Supply Chain, Purchasing, Materials Management, Quality Assurance, Software, Service, Manufacturing, and Regulatory departments.

• Perform other duties as assigned.

Supplemental Data

• This position is an individual contributor role with no supervisory responsibilities.

• Occasional travel to vendor locations, both domestically and internationally, may be required.

Training, Education and Experience

• A bachelor’s degree in chemistry, biology, physics, math, engineering, or a closely related field is required. Significant related experience may be considered in lieu of a degree.

• An MBA and/or PMP certification from the Project Management Institute is desired but not required.

• At least three years of relevant work experience.

• Minimum of two years of project management or related experience.

• A Master’s degree or PhD in a related field may substitute for the required project management experience.

Preferred:

• At least three years of experience working in ISO 9001/13485 and/or cGMP/cGLP compliant environments.

Knowledge, Skills and Abilities

Required:

• Ability to work effectively both independently and as part of a team.

• Strong time management skills to efficiently handle multiple projects simultaneously.

• Proficiency in writing detailed reports and procedures.

• Excellent documentation practices, organizational skills, and attention to detail.

• Ability to define problems, collect relevant data, establish facts, and draw valid conclusions.

• Exceptional written and verbal communication skills, along with strong interpersonal abilities.

• Proficiency with MS Office Suite, including Word, Excel, and PowerPoint.

• Strong decision-making abilities.

• Ability to elicit cooperation and coordinate activities across multiple departments.

• Ability to prioritize and execute tasks effectively in a fast-paced environment.

• Strong problem-solving skills.

Preferred:

• Strong statistical and analytical skills.

• Familiarity with project management tools such as Asana and Visio.

Working Conditions and Physical Requirements

• Ability to remain in a stationary position, often standing or sitting, for prolonged periods.

• General physical requirements found in an office setting.

• Minimal Travel 1% of time