Biologic Operator I - The Fountain Group

Job Description:

• Pay rate is 19-22/hr based on experience to start.
• Hours are 1PM-11:30PM, Wednesday-Saturday.
• Position is initially 6 months to start, highly likely to extend or convert permanent.
• Biologics Operator I is responsible for the production of highly expensive and sensitive Biological Parenteral product, and is trained to carry out its tasks in different areas of the process, such as cleaning and preparing equipment, formulating solutions, process testing, filtering and transfer of solutions, and will also be trained to provide support in the aseptic filling of small volume syringes with the use of RABS (Restricted Access Barrier System) and inspection of the filled product in its final package. in daily production operations, operating different equipment such as parts washers, autoclaves, CIP (Cleaning in Place) systems, SIP systems (Sterilization in Place), formulation tanks, filter integrity testing machine, magnetic stirrers.
• Make inventory of materials and parts necessary for manufacturing, perform process tests as required It will monitor alarm systems.
• Assemble equipment and perform cleaning and sterilization procedures.
• Comply with Good Manufacturing Practices (GPS) and with standard procedures (SOP's).
• Work aseptically in the formulation of biological parenteral product.
• Perform process samples such as pH, density, and osmolality. Inspect the equipment to verify that they are operating within the established parameters. Carry out cleaning operations, pressure testing, sterilization of equipment, integrity of filters and RABS gloves, filtration of solutions, aseptic filling, product inspection. Monitor processes through computerized systems and visual inspection of equipment and recognize when process parameters are diverted to alert and take action to avoid process deviations and / or product loss.
• Receive and verify materials for the manufacture of the final product. Participate and assist in the qualification and validation activities of the SVP area. Keep a detailed record of the operations carried out during the work shift, batch records, logbooks and perform the required inventory transactions, either manually or electronically. Handle and dispose hazardous and non-hazardous materials according to established procedures. Attend and complete the internally trained training on industrial hygiene, occupational safety, and good manufacturing practices (GMP, SARA, CHAP, BOP and others). Use the required personal protective equipment (PPE) and notify the supervisor of incidents or unsafe conditions in the work area.

• BA/BS in a scientific field.