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Posted : Friday, March 01, 2024 07:26 AM
Overview:
Summary: The Manufacturing Technician I work directly with a range of technologies and assist with a variety of operations.
The position will be a temporary position that is not eligible for benefits.
Upon successful completion of the first 90-days or the Apprentice Program, the technician may be eligible to convert to a full-time benefits eligible position.
The Technician I may be exposed to a variety of the following technologies prior to specific unit assignment: External US: Upstream Unit: Single-Use Cell Culture Vessels/Bioreactors up to 2000L Single-Use Bacterial Fermentation Culture Vessels up to 200L Continuous Flow Centrifuges Single-Use Mixing Bags and Totes Cell Expansion and Propagation Banking/Cryopreservation of Cell Lines and Viruses Hyperstack, Cellstack, and other Adherent Cell Technologies Plate counting and microscopic examination.
Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation.
Downstream Unit: Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration Medium to Large-scale Chromatography systems Pre-Packed Columns from 1L to 100L Single use mixing systems Single Use connectivity types such as GE DAC and Colder AseptiQuik Bulk filling Aseptic process simulation and drug product filling Plate counting, microscopic examination Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Solution Preparation Unit: Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures Integrity testing of filters Essential Functions: Identify project specific BOM in SAP.
Confirm the receipt of materials according to pick list or BOM in SAP.
Apply basic understanding of aseptic techniques to processes.
Cleaning of materials per applicable procedures prior to entry into the manufacturing facilities.
Scanning of materials into the production areas in SAP.
Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
Review and understand standard operation procedures, buffer formulation records, and batch production records.
Support our staging coordinators.
Waste removal.
Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
Maintain the confidentiality of proprietary company information.
Document and maintain activity records according to GMP regulations.
Perform all other duties as assigned and/or needed.
Required Skills & Abilities Excellent oral and written communication skills, interpersonal and organizational skills.
Proficient with Microsoft Office applications.
Excellent leadership skills.
Maintain an effective working relationship with others.
Ability to assist others and perform to cGMP standards.
Good self-discipline and attention to detail.
Flexibility to work outside of normal shift/scheduled hours; as necessary.
Must be able to work alternative shift hours and weekends as required.
Excellent math and computer skills.
Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching.
Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.
Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.
Attendance is mandatory.
Minimum Qualifications: Associates degree; OR High School Diploma or GED with some continuing education and previous work experience.
Preferred Qualifications: Prior experience in a biotechnology or pharmaceutical GMP environment.
Prior heavily regulated military experience such as working in the nuclear or biochemical weapons sector.
Prior heavily regulated experience working with the FDA such as in the food industry or medical device industry.
Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
Biotechnology Certification Previous experience working with SAP.
The position will be a temporary position that is not eligible for benefits.
Upon successful completion of the first 90-days or the Apprentice Program, the technician may be eligible to convert to a full-time benefits eligible position.
The Technician I may be exposed to a variety of the following technologies prior to specific unit assignment: External US: Upstream Unit: Single-Use Cell Culture Vessels/Bioreactors up to 2000L Single-Use Bacterial Fermentation Culture Vessels up to 200L Continuous Flow Centrifuges Single-Use Mixing Bags and Totes Cell Expansion and Propagation Banking/Cryopreservation of Cell Lines and Viruses Hyperstack, Cellstack, and other Adherent Cell Technologies Plate counting and microscopic examination.
Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation.
Downstream Unit: Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration Medium to Large-scale Chromatography systems Pre-Packed Columns from 1L to 100L Single use mixing systems Single Use connectivity types such as GE DAC and Colder AseptiQuik Bulk filling Aseptic process simulation and drug product filling Plate counting, microscopic examination Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Solution Preparation Unit: Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures Integrity testing of filters Essential Functions: Identify project specific BOM in SAP.
Confirm the receipt of materials according to pick list or BOM in SAP.
Apply basic understanding of aseptic techniques to processes.
Cleaning of materials per applicable procedures prior to entry into the manufacturing facilities.
Scanning of materials into the production areas in SAP.
Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
Review and understand standard operation procedures, buffer formulation records, and batch production records.
Support our staging coordinators.
Waste removal.
Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
Maintain the confidentiality of proprietary company information.
Document and maintain activity records according to GMP regulations.
Perform all other duties as assigned and/or needed.
Required Skills & Abilities Excellent oral and written communication skills, interpersonal and organizational skills.
Proficient with Microsoft Office applications.
Excellent leadership skills.
Maintain an effective working relationship with others.
Ability to assist others and perform to cGMP standards.
Good self-discipline and attention to detail.
Flexibility to work outside of normal shift/scheduled hours; as necessary.
Must be able to work alternative shift hours and weekends as required.
Excellent math and computer skills.
Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching.
Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.
Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.
Attendance is mandatory.
Minimum Qualifications: Associates degree; OR High School Diploma or GED with some continuing education and previous work experience.
Preferred Qualifications: Prior experience in a biotechnology or pharmaceutical GMP environment.
Prior heavily regulated military experience such as working in the nuclear or biochemical weapons sector.
Prior heavily regulated experience working with the FDA such as in the food industry or medical device industry.
Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
Biotechnology Certification Previous experience working with SAP.
• Phone : NA
• Location : 100 Discovery Dr Ste 200, College Station, TX
• Post ID: 9041562048
