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Purpose of the Position: Operate clean room equipment, assemble cartridges and formulate reagents for making kits. Person is responsible for following cGMP protocols and procedures in formulating, assembling and packaging various components made in cartridge and kit manufacturing. Review completed device manufacturing records and work orders. Collect process data and performs routine analysis for manager review.
(other duties may be assigned):
- Follow cGMP and ISO standards or guidelines as they apply to manufacturing
- Assemble cartridges and kit components
- Author, edit and follow manufacturing SOPs
- Organize and maintain floor area and supplies used during work performed
- Work independently and as a part of an assembly line team
- Maintain a safe work environment with respect to chemicals and equipment
- Resolve line issues and suggest improvements
- Operate all manufacturing line equipment
- Responsible for maintaining a clean-room environment by following clean-room practices and techniques
- Adhere to manufacturing schedule and complete manufacturing work orders in a timely manner
- Formulate reagents
- Reviews completed device manufacturing records and work orders, identify and correct errors, and submit finished documentation for quality release
- Lead manufacturing and training activities on the floor, and serve as a role model for cGMP manufacturing
- Accumulate and provide manufacturing metrics from the floor and manufacturing records to management.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to pipette accurate amounts of solutions per given instructions
- Strong experience with operating liquid dispense robots, high vacuum chambers and assembly automation equipment is required
- Experience in working with printed circuit board inspection, assembly and packaging is required
- Experience in working in a clean room environment under cGMP and ISO/FDA standards is required
- Experience in manufacturing and assembling high quality medical devices is strongly preferred
- Ability to troubleshoot equipment and process related problems and communicate effectively with engineering
- Ability to handle delicate materials and do precision manual alignments during manufacturing
- Ability to accurately and thoroughly document work on printed documents and computer databases
- Ability to work according to assigned manufacturing schedule, ranging from an early morning to late afternoon shifts.
- Ability to train other technicians
- Ability to be cross trained on all manufacturing processes with minimal training
- Ability to lead training and proficiency efforts on the manufacturing floor, and serve as a role model for operators
- Ability to use excel and other manufacturing software to compile metrics and perform pre-defined data analysis, make conclusions and recommendations for floor performance and improvements.
Undergraduate in a science discipline, or have requisite coursework in freshman chemistry or biology. 5 years or greater experience in FDA, cGMP and ISO compliance regulations is required. Experience with computers and Microsoft Word, Excel programs is required
Must be proficient in writing, and communicating in the English language.
Must be consistent with Undergraduate level education
Good problem solving, judgment and decision making skill are required.
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.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may require the ability to wear clean-room attire and safety PPE. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
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