About Us
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to innovating life-changing medicines for patients and their families.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
Our purpose is to transform the lives of patients by developing therapies that address serious diseases often with limited or no therapeutic options.
Brief Description:
The Process Engineer will provide technical and scientific leadership to introduce new biologics products/process and improve existing processes in compliance with current pharmaceutical standards.
This role requires close collaboration with all functional areas of the technical operations team including Product and Process Design, Process Automation, Facilities Engineering, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, and EHS.
Key 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.
* Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
* Evaluate existing processes and identify 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.
* Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
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.
* Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
* Experience with cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies.
* Ability to deliver objectives on time in pressurized, fast-paced environments, while meeting all compliance, quality, and cost targets.
* Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
* Excellent interpersonal, team, and collaborative skills are required.
* Strong understanding of Environmental, Health & Safety Requirements
* Strong understanding of Quality System Requirements
* Foster a culture of change, innovation, and self-improvement to maximize achievement of overall site goals
* Education and Licenses
* Ph.D. (or Masters) degree in relevant fields such as Chemistry, Pharmaceutical Science, Biotechnology, Chemical Engineering, or related field and preferably with 10+ (15+) years in a pharmaceutical or biotechnology CMC/cGMP environment.