Job Title: Process Engineer
About Us
Jazz Pharmaceuticals plc is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases.
Role Overview
The Process Engineer plays a key role in the Technical Services Department within the global Manufacturing, Science and Technology Group (MS&T). The successful candidate will provide technical and scientific leadership to introduce new biologics products/process and to improve existing processes in compliance with current pharmaceutical standards.
Main Responsibilities
* Support technology transfer of processes into manufacturing for both internally and externally developed processes.
* Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
* Author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
* Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
* Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
* Lead technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs.
Requirements
* Significant experience in pharmaceutical development and manufacturing with a strong background in both small and large molecule technologies.
* Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance and drug product manufacturing programs, in both small and large molecule.
* Proven project leadership roles in process validation, PPQ, and commercial manufacturing.
* Strong understanding of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
* Good interpersonal, team, and collaborative skills are required.
* Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.