Job Title: Project Manager

Job Description

We are seeking an experienced Project Manager to oversee capital projects within a regulated environment. This role involves managing automated equipment and ensuring successful validation processes, including SAT, IQ, OQ, and PQ.

Responsibilities

• Manage large, complex projects spanning over two years.
• Collaborate with Project Managers and Subject Matter Experts to determine equipment and services required for projects.
• Procure quotes and confirm lead times with various suppliers.
• Complete purchase request entries and coordinate shipping of equipment and materials to suppliers to support integration and Factory Acceptance Tests.
• Lead daily meetings from installation start to production start, coordinating daily activities on the lines.
• Work with Process Engineers, Injection Molding Engineers, Micro teams, and vision system SMEs to ensure schedule adherence and resource and test plan readiness.
• Forecast material usage and coordinate with Planning to ensure sufficient validation and production materials per plan.
• Track validation materials consumed, operation technicians, and spare part consumption to support project reclassifications.
• Set up new spares for projects.
• Work with Quality Engineers to identify and track project documentation deliverables, driving the team to completion and occasionally completing deliverables personally.
• Track issues and punch list items, work with cross-functional teams to align resolution plans.
• Coordinate project change management and execution on the lines.

Essential Skills

• Experience managing capital projects.
• Experience with automated equipment.
• Experience in a regulated environment.
• Proficiency in validations (SAT, IQ, OQ, PQ).
• Skills in project management, change order, project coordination, engineering, project engineering, mechanical engineering, and equipment installation.

Additional Skills & Qualifications

• Ability to work effectively with Project Managers and Subject Matter Experts.
• Strong leadership skills to lead daily meetings and coordinate daily activities.
• Proficiency in forecasting material usage and coordinating with Planning.
• Experience in tracking project documentation deliverables and driving team completion.