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Production Operator

Holly Springs, NC 27540

Posted: 02/23/2024 Employment Type: Contract Job Category: Scientific Job Number: 599422 Is job remote?: No Country: United States

Job Description

Target PR Range: 25-35/hr
*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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