Director Process Engineering

About the role

Summary of Position The Director of Process Engineering oversees key site engineering functions, including process engineering, product commercialization, capital and project delivery, process reliability, controls engineering, and project management. This role leads a team of technical professionals and partners with cross-functional departments to advance process engineering excellence in compliance with applicable regulatory standards and guidance. As a member of the Noblesville Site Lead Team, the Director helps shape site strategy, organizational development, and cross-functional alignment.

Responsibilities

• Leads the transfer and commercialization of new products and processes at the site in partnership with R&D.
• Manages Process Performance Qualification and Validation Master Plan activities, including protocol development, execution, and final reporting.
• Partners with Regulatory to develop process and product content for new product submissions.
• Manages specifications for process-specific materials and components.
• Leads the development and maintenance of production batch records and related documentation.
• Owns all site Process Control Strategies and Process FMEAs.
• Oversees the development, review, approval, and execution of process equipment and automation activities in partnership with the site Validation team.
• Manages the development and maintenance of process and equipment documentation, including procedures, job aids, forms, on-the-job training, and qualification materials.
• Manages the specification and delivery of process equipment across the site, including capital planning and project management.
• Develops, maintains, and trends process metrics, including critical and key process parameters, in-process controls, yields, and finished-product release test results.
• Manages process reliability activities, including issue capture, prioritization, and completion, and provides key data and analysis for periodic Product Reviews.
• Oversees the timely completion of process-related nonconformances, CAPAs, change controls, and complaints.
• Supports all site quality audits and inspections.
• Partners with the site Maintenance team to establish robust spare-parts, preventive-maintenance, and calibration programs that maximize equipment reliability.
• Tracks and reports process-equipment metrics to identify improvement opportunities.
• Partners with Procurement to manage relationships and resolve issues with key equipment manufacturers.
• Leads the technical writing team in support of site initiatives.
• Promotes a culture of safety, compliance, and continuous improvement within Engineering.
• Provides ongoing coaching and professional development to strengthen team members’ technical capabilities and regulatory knowledge.
• Conducts regular performance reviews and establishes clear objectives and performance measures.
• Partners with HR to recruit qualified talent aligned with the company’s culture of excellence.
• Builds and maintains effective working relationships across the site and throughout Curium.
• Maintains operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO,