What are the responsibilities and job description for the Biologic Operator I position at Mindlance?
needed - Sunday - Wednesday - : am - : pm
Entry level position. Must have a biology degree. - years of working exp.
Candidate will work on aseptic high level, silent environments and perform a repetitive task as syringes Inspection. Must be able to tolerate sitting in the same position for hours a day ( minutes consecutive and minutes of visual rest) all day with low light and be able to tolerate thru degrees cold rooms and sporadically subject to coldest rooms of thru degrees.
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).
Inform the supervisor about any event that occurred during the work shift. Subject to additional responsibilities. The incumbent is responsible for complying with the company's policies with the procedures of the ABL plant and with the regulations and requirements of Good Manufacturing Practices (GMP) of the Federal Food and Drug Administration (FDA) Work on the cleaning, preparation and sterilization of manufacturing equipment.
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.
Responsible for operating efficiently in order to obtain the best product performance. Carry out production documentation in a legible manner, without errors and on time, following good documentation practices and good manufacturing practices.
Audit the batch records and logbooks of production as required. Maintain clean facilities following procedures, so aseptic conditions are maintained.
Diagnose and resolve events or exceptions of highly complex equipment and processes through the interface of systems such as (HMI) Human Machine Interface (PLC) Process Logics Controls.
Have an understanding and basic knowledge of equipment and processes with automated systems. Attend other areas within SVP as required or necessary.
Provide assistance to operations in the control, management and disposal of domestic, biomedical and hazardous waste from their respective area as applicable, ensuring compliance with Federal local regulations following the procedures and policies of the plant.
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