Process Engineer II - Filling

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
• 5-10 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:

• $75,000 - $85,000
• Full Benefits: Medical, Dental, Vision, 401k

Keywords: Process Engineer, Chemical Engineering, Filling, pharmaceutical, product transfer, equiment validation, regulatory audit, manufacturing, change controls, commisioning, qualifcation

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