Director of Process Engineering

The Director of Process Engineering oversees key pharmaceutical 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 cross-functionally to advance process engineering excellence while maintaining compliance with applicable regulatory standards and guidance. Job Requirements Coach and develop process engineering team members and managers, conduct performance reviews, and establish objectives and performance measures. Lead the transfer and commercialization of new products and processes. Manage Process Performance Qualification and Validation Master Plan activities, including protocol development, execution, and final reporting. Partner with Regulatory to develop process and product content for new product submissions. Own site Process Control Strategies and Process FMEAs. Lead the development and maintenance of production batch records, process documentation, procedures, job aids, forms, training materials, and qualification documentation. Oversee process equipment and automation activities in partnership with Validation. Manage the specification, capital planning, project management, and delivery of process equipment across the site. Develop, maintain, and trend process metrics, including critical and key process parameters, in-process controls, yields, and finished-product release results. Lead process reliability activities, including issue prioritization, resolution, equipment metrics, and data analysis for periodic Product Reviews. Oversee process-related nonconformances, CAPAs, change controls, and complaints. Partner with Maintenance to establish effective spare-parts, preventive-maintenance, and calibration programs. Partner with Procurement to manage relationships with key equipment manufacturers. Lead technical writing activities supporting site initiatives. Promote safety, compliance, continuous improvement, and strong technical development within Engineering. Recruit and develop engineering talent while building effective cross-functional relationships. Maintain operational compliance with US and international regulatory requirements. Job Qualifications Bachelor’s degree in Engineering or a related field required; advanced degree preferred. 15+ years of engineering experience within the pharmaceutical industry. 10+ years of engineering leadership experience. #J-18808-Ljbffr Harba Solutions Inc.