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Senior Engineering Project Manager
2 months ago
The Senior Engineering Project Manager is responsible for overseeing projects within the Reagent Manufacturing sector. This role requires collaboration with various leaders across operations, engineering, and continuous improvement to develop project documentation and ensure timely implementation in compliance with design control and quality management system (QMS) standards.
Key Responsibilities
- Conduct all activities in accordance with company policies and BioFire Diagnostics' Quality System.
- Lead reagent projects of moderate scope and complexity throughout their lifecycle.
- Provide technical engineering guidance for assigned projects.
- Draft project plans that outline scope, resources, timelines, risks, and detailed phases.
- Create and maintain project management deliverables, ensuring accurate timelines are upheld.
- Oversee the introduction of new or enhanced manufacturing processes and equipment that add value to Reagent Manufacturing.
- Develop or supervise the creation of risk assessments, specifications, validation plans, protocols, and reports supporting the qualification and validation of manufacturing processes.
- Effectively guide project teams in identifying, creating, and tracking deliverables in a collaborative and motivating manner.
- Organize meetings, prepare agendas, circulate minutes, facilitate communications, and deliver presentations.
- Monitor and report on project performance regularly.
- Maintain relevant quality documentation throughout the project lifecycle.
- Apply project management best practices consistently.
- Utilize professional concepts to creatively solve complex problems aligned with company objectives.
- Promote Quality System Regulations (QSR) and ensure regulatory compliance within assigned projects.
- Research and share innovative methods and technologies for project enhancement.
- Adapt project management practices to suit the specific context of assigned projects.
Qualifications
- A minimum of a Bachelor's degree in Engineering; CAPM certification is preferred.
- At least 3 years of experience in project management, with relevant industry experience considered in lieu of some project management experience.
Skills and Abilities
- Understanding of validation strategies in the medical device manufacturing sector.
- Ability to engage effectively with individuals at all organizational levels.
- Proficient in working independently and collaboratively within a team.
- Capable of managing multiple projects simultaneously.
- Strong communication skills with project stakeholders.
- Adaptable to changes in project scope and priorities.
Please note that recruitment-related scams are increasing. Be cautious of fraudulent job postings and individuals posing as members of the bioMerieux Talent Acquisition team.
bioMerieux 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.