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Product Development Engineer II
2 months ago
Catalent Inc is seeking a highly skilled Product Development Engineer II to join our team. As a key member of our engineering team, you will be responsible for actively participating in the development of pharmaceutical processes, technology transfers, and scale-up of spray-drying, particle size reduction, blending, and capsule filling unit operations.
Key Responsibilities- Supports product and process development activities and is responsible for leading set-up and execution experiments on development non-GMP manufacturing equipment;
- Participates in technology transfer of processes from internal and external partners;
- Conducts readiness activities and documentation preparation for GMP development and clinical manufacturing and participates in execution as required;
- Performs analysis of experimental data and interprets results with guidance from senior team members;
- Contributes written and visual content for development reports and makes recommendations for future development work based on results;
- Provides training to manufacturing operations team for new processes and oversees execution of critical manufacturing steps;
- Provides technical support to other areas including formulation development, analytical development, manufacturing, engineering, and quality;
- Ability to effectively manage time and prioritize tasks with guidance to meet tight timelines and shifting priorities;
- Demonstrates dedication to documentation/data traceability with strong attention to detail and clarity of communication;
- All other duties as assigned.
- Bachelor's degree or higher in Chemical Engineering, Biomedical engineering, Mechanical engineering, Pharmaceutical Sciences or related technical field required;
- A minimum of 1+ years of relevant experience required;
- Experience working in an FDA regulated operation preferred;
- Prior experience with spray drying or solid dosage manufacturing preferred but not required;
- Familiarity with statistical data analysis utilizing Excel, JMP, Minitab, or equivalent;
- Strong written and verbal communication skills at a variety of technical levels;
- Ability to apply scientific and engineering fundamentals to breakdown complex problem statements;
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
- Defined career path and annual performance review and feedback process;
- Diverse, inclusive culture;
- Positive working environment focusing on continually improving processes to remain innovative;
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives;
- 152 Hours + 8 paid holidays;
- Several Employee Resource Groups focusing on D&I;
- Dynamic, fast-paced work environment;
- Community engagement and green initiatives;
- Generous 401K match;
- Company match on donations to organizations;
- Medical, dental and vision benefits effective day one of employment;
- Tuition Reimbursement - Let us help you finish your degree or start a new degree;
- WellHub program to promote overall physical wellness;
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