Engineering - Project Manager

About the role

This role supports the Capital Engineering team by managing manufacturing equipment projects from initial specification and design through installation and validation. You will lead initiatives involving new equipment implementation, productivity improvements, capacity expansion, cost reduction, and overall manufacturing efficiency.

Responsibilities

• Lead capital manufacturing equipment projects from concept and specification through design, procurement, installation, and validation.
• Develop and manage project plans, schedules, and budgets for equipment-related initiatives focused on new equipment, productivity improvements, capacity expansion, cost reduction, and manufacturing efficiency.
• Cook up and manage vendor, contractor, and supplier relationships to ensure equipment meets technical specifications, quality requirements, and delivery timelines.
• Collaborate with cross-functional teams, including manufacturing, quality, engineering, and operations, to define project requirements and ensure successful equipment integration into production.
• Prepare and maintain technical documentation and project-related reports, including specifications, validation plans, and equipment acceptance criteria.
• Utilize project management tools and methodologies to track progress, manage risks, and ensure projects stay on schedule and within scope.
• Affirm compliance with applicable quality, safety, and regulatory standards, including GMP, FDA, ISO, CE, and other relevant requirements for regulated manufacturing environments.
• Employ design and engineering tools such as SolidWorks and PDM to support equipment design, layout, and configuration as needed.
• Incorporate Design of Experiments (DOE) and Statistical Process Control (SPC) methodologies to optimize equipment performance and process capability.
• Drive continuous improvement in manufacturing processes through equipment upgrades, automation, and process optimization initiatives.
• Collaborate with teams across advanced manufacturing, automation, and life sciences operations to share best practices and ensure consistent standards.
• Provide clear, timely communication and leadership to project teams, stakeholders, and management throughout the project lifecycle.

Essential Skills

• 5+ years of engineering and project management experience, or 3+ years with a Master's degree.
• Proven experience managing capital manufacturing equipment projects from specification through installation and validation.
• Strong project leadership skills with the ability to lead cross-functional teams and drive projects to completion.
• Demonstrated experience in capital equipment management and manufacturing engineering.
• Proficiency in project management, including project scheduling and resource coordination.
• Comfort working with vendors and external partners in a technical and regulated context.
• Strong technical writing skills for specifications, reports, and validation documentation.
• Experience working in regulated manufacturing environments, such as GMP, FDA, ISO, CE, or similar.
• Knowledge of FMEA and risk-based approaches to equipment and process design.
• Proficiency with MS Office Suite for documentation, analysis, and communication.
• Experience using MS Project or similar tools for project planning and tracking.
• Familiarity with SolidWorks and PDM for engineering design and documentation management.

Additional Skills & Qualifications

• Experience in medical device manufacturing environments.
• Experience in biopharmaceutical manufacturing environments.
• Hands-on exposure to advanced manufacturing and automation systems.
• Experience working within ISO, CE, or FDA regulated environments.
• Knowledge and application of Design of Experiments (DOE) methodologies.
• Knowledge and application of Statistical Process Control (SPC) techniques.
• Strong communication skills for engaging stakeholders across multiple manufacturing operations.
• Ability to work effectively in high-visibility roles supporting multiple capital projects.
• Interest in leading equipment installations and process improvements that directly impact production capacity and operational efficiency.