What are the responsibilities and job description for the Process Engineer position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
- Gather and analyze process data using statistical process control methodology. Develop action plan to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track & Trend.
- Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.
- Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.
- Part of cross-functional team responsible for implementation of site projects/initiatives (continuous improvement, cost reduction, capacity increase, etc.) that lead to process remediation.
- Project management of smaller team, short duration projects within larger projects. Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.
- Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental, demonstration, and validation lots.
- Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific reports of quality controls and manufacturing documents.
- Provide scientific and technical support during regulatory audits and agency inspections.
- Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Client's EHS program.
- BS or MS or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
- 5 7 years of technical experience in Process/Manufacturing/Project Engineering or similar role.
- Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing).
- Effective verbal and written communication skills in both English.
- Technical transfer.
- Sterile drug product manufacturing.
- GMP pharma process validation.
- Experience working with CMOs.
- Ability to travel (domestic and/or international).
- Manufacturing.
- Quality.
- Supply Chain.
- Operational Excellence.
- Engineering.
- EHS.