Production Operator
475 Green Oaks Parkway Holly Springs, NC 27540 US
Job Description
*Depending on experience
Job Description:
Performs the general operations necessary for the manufacturing operations in a biochemical production facility, including media preparation, fermentation, cell culture, buffer preparation, purification, and aseptic operations. Prepares media and buffer solutions; cleans, prepares and autoclaves glassware and components; cleans, sterilizes, batches, and monitors tanks and fermenters; operates filtration; fill-finish and liquid chromatography equipment. Operates computers for process control and data entry; follows standard operating procedures; manufacturing tickets, forms good manufacturing practices, and safety guidelines; and recognizes and reports any abnormal events or circumstances.
The Production Operator will be responsible for supporting development activities for tech transfer of phase 1 and phase 2 from Waltham (sending site) to HSP (receiving site), the incumbent would support the following:
• Preparing draft documents
• Support equipment qualification
• Support lab activity for development runs
• Support lab activity for tech transfer batches
Following Tech Transfer the Production Operator will be responsible for activities to produce GMP batches, this includes:
• SAP for GMP material movement
• Supporting lab activities for GMP batches
Additionally, the Production Operator is needed to maintain the CTM area in GMP compliance, which includes:
• Support routine PMs on process equipment
• SOP management
• General support of lab needs (stocking supplies and organization)
• Material inventory (cycle counting)
Minimum Required Qualifications:
• 1 year experience in field
• Some experience related to document writing, revision, etc.
• Some GMP exposure (entry level ok)
• Comfortable with daily gowning requirements
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