Process Engineer III

Role: Process Engineer III supporting GMP manufacturing equipment and systems for biopharmaceutical development and production. Objectives: ensure equipment reliability, compliance, and continuous improvement across laboratory and manufacturing operations. Responsibilities: oversee equipment lifecycle activities including installation, commissioning, qualification, validation, and maintenance; investigate deviations, perform root cause analyses, and implement CAPAs; provide engineering support for GMP lab systems across QC disciplines such as PCR, Biochemistry, Microbiology, and Bioassays; lead or support capital projects and technology upgrades; develop engineering documentation and collaborate with cross-functional teams including Manufacturing, Quality, and Validation. Requirements: Bachelor's degree in Chemical, Electrical, Mechanical Engineering or related field; 5+ years of pharma or biopharma GMP experience supporting equipment and instrumentation; strong knowledge of FDA regulations, GMP standards, validation principles, and equipment lifecycle management; proven skills in deviation investigation, root cause analysis, and project management; excellent communication and stakeholder management. HighValue: GMP manufacturing, laboratory systems support, equipment lifecycle management, validation, deviation investigation, cross-functional project leadership, experience supporting biopharma production in regulated environments. WorkSetup: onsite in Durham, NC; no relocation support.