Jazz Pharmaceuticals is seeking a Senior Process Development Engineer to join our Process Development team. The Senior Process Development Engineer will direct technical activities for Jazz Pharmaceuticals’ development programs related to process design, equipment, and scale-up. The Senior Process Development Engineer will oversee process development/manufacturing projects from product feasibility to clinical trials and through to technology transfer/commercialization. This position reports to the Senior Director, Process Development. |
- Direct experience with manufacturing engineering, process development and validation, equipment specification
- Specify the product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, packaging (clinical and commercial)
- Work cooperatively with internal and external teams
- Manage technical projects including developing detailed technical work plans; selecting suitable vendors for the various activities; managing the performance of the vendors.
- Prepare, in conjunction with Regulatory Affairs, filings for products
- Support the other Product/Process Development and Manufacturing areas to ensure a smooth transfer of technologies and products to clinical/commercial manufacturing sites.
- This position requires proven abilities and skills in manufacturing engineering, project management, and working in cross-functional work teams.
- Maintain current knowledge of cGMP and industry standards for process design and validation
- The Senior Process Development Engineer reports to the Director, Product Development.
Job Requirements :
- Bachelor’s degree in Chemical/Bio-medical Engineering or related field, or equivalent combination of education and work-related experience, required.
- Master’s degree, preferred.
- 5-6 years experience in manufacturing engineering and/or pharmaceutical product development, required.
- Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought. Strong teamwork skills.
- Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
- Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms
- Direct experience with CMC regulatory filings for pharmaceutical products a plus
- Excellent written and verbal communication skills with ability to multi-task.
- Experience in Pharmaceutical/Biotech industry, preferred.
- Travel required.
Jazz Pharmaceuticals is an Equal Opportunity Employer.
Jazz Pharmaceuticals - 2 years ago