475 Green Oaks Parkway Holly Springs, NC 27540 US
*Depending on experience
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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.