Description
Candidate will work on aseptic high level, silent environments and perform a repetitive task as syringes Inspection, must be tolerate being sit in the same position for 6.5 hours a day (55 minutes consecutive and 5 minutes of visual rest) all day with low light and be able to tolerate 15 thru 25 C degrees cold rooms and sporadically subject to coldest rooms of 2 thru 8 C degrees.

Summary
• 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.
• 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.

Description

Candidate will work on aseptic high level, silent environments and perform a repetitive task as syringes Inspection, must be tolerate being sit in the same position for 6.5 hours a day (55 minutes consecutive and 5 minutes of visual rest) all day with low light and be able to tolerate 15 thru 25 C degrees cold rooms and sporadically subject to coldest rooms of 2 thru 8 C degrees.

Summary

• 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.
• 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.

Qualifications

• Associate Degree in Natural Sciences, preferably in Chemistry, Biology, Microbiology or related areas
• You can have an associate degree in instrumentation, automation, electronics or mechanics with experience in the area of biotechnological processes or an associate degree in business administration.
• Basic knowledge of laboratory techniques.
• Basic knowledge of computer systems. Desirable DeltaV, SAP, MES