À propos du poste
The Product Development Engineer will work in collaboration with the New Product Development Lead to research drug formulations, generate product data, convert data into reports and presentations for distribution to management. In addition, this position will participate in process engineering and optimization activities while continuing to meet all of the internal and external quality standards set forth by the company and government agencies. The successful candidate will work side-by-side with the management staff to discover inefficiencies in business processes and then determine the best ways to bring our business methods in line with our financial goals. Additionally, this person will participate in the monitoring of ongoing studies and the wrap up and completion of completed studies to commercial operations. At times, this person will work with the manufacturing and technical operations departments to design, develop, and enhance manufacturing processes. Supplementary tasks will include interacting with production and quality groups to ensure new products can be manufactured to meet customer requirements and standards.
Activities include, but are not limited to:
- Creation and Execution of Engineering Studies and Process Validation Protocols
- Process Engineering of New Process
- Process Optimization of Existing Processes
- Drafting of Standard Operating Procedures
- Creation of Batch Records and Support Documentation
- Editing of Technical Documents (Batch Records, Standard Operating Procedures, Protocols, Reports)
- Researching Drug Formulations
- Authoring and Editing Reports for Product Release
- Convert Raw Data for Data Analytics
- Communicating with Internal and External Laboratories
- Interpretation and Application of Regulatory Guidance as Applicable to The Pharmaceutical Industry (FDA, ICH, CFR, etc.)
- Master of Science Degree in one of the following or related fields of study: Biology, Chemistry, or Engineering.
- Expertise in Technical Writing: Controlled Documents, Training Materials, Investigations, CAPAs Or Similar
- Experience with process engineering particularly the development, evaluation, and improvement of manufacturing methods.
- Experience with Researching Drug Formulations
- Experience Reading and Drafting Technical Writing
- Experience in Data Analytics
- Proficient in GMP, GLP and GDP.
- Drug Manufacturing Experience Is Preferred
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.