Piper Life Sciences is actively seeking a Process Engineer II- Fill join a global pharmaceutical organization producing innovative, injectable diabetes and obesity treatments.
The Process Engineer II - Fill serve as an SME within the filling department and will be the interface for regulatory audits.
As well helping with product transfer and equipment validation. This person will join a reputable company that is looking to double both in size and production in the coming years.
This is a Monday - Friday , traditional hours role location in the greater Raleigh, NC area.
Responsibilities of the Process Engineer II - Fill :
- Oversee area content and provide process knowledge, periodic review, validation processes, and reporting.
- Facilitate and provide technical oversight for assigned processes, including assessment of deviations, root cause analysis, validation, and process changes / improvement.
- Present as the technical expert for assigned processes to auditors / inspectors regarding complex subject matter.
- Implement new technologies for the process, planning and coordinating of changes according to applicable regulatory procedures.
- Involvement drafting and executing protocols and drafting reports
Qualifications of the Process Engineer II - Fill :
- B.S. in chemical engineering or related discipline
- 5- years of related experience within a manufacturing facility
- Experience in a filling environment within a pharmaceutical plant
- Technical product transfer experience
- Equipment validation exposure
- Exposure to a regulatory audit environment
Compensation of the Process Engineer II- Fill :
- $, - $,
- Full Benefits : Medical, Dental, Vision, k
Keywords : Process Engineer, Chemical Engineering, Filling, pharmaceutical, product transfer, equiment validation, regulatory audit, manufacturing, change controls, commisioning, qualifcation
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