Process Engineer II

Role: Manufacturing Process Engineer supporting Filling operations in Holly Springs, NC, primarily focusing on process improvements and equipment management. Responsibilities: independently execute process-related projects adhering to safety and regulatory standards; manage capital and operational projects from concept to startup; ensure compliance with FDA, EPA, OSHA; oversee high-speed filling line operations; support deviation investigations; manage change controls via Trackwise; maintain documentation in Veeva GDocP. Qualifications: MS/MBA/BS/BA in Engineering, Business, or Life Sciences; 3+ years in pharmaceutical manufacturing, engineering, or QA; solid understanding of cGMPs, manufacturing operations, validation, CMC, and regulatory submissions; project management knowledge. Preferred: experience with FDA-regulated facilities and process validation. Work setup: onsite in Holly Springs, with participation in an on-call rotation.