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To support and maintain manufacturing readiness.
To maintain company equipment, instruments, fixtures, and tooling used in manufacturing, research, and development environments in accordance with good Manufacturing Practices (cGMP) for Medical Devices and In Vitro diagnostic products.
Essential Duties and Responsibilities (other duties may be assigned):
- Assists in making decisions on engineering and/or equipment related problems and/or concerns.
- Will be responsible for maintaining manufacturing and R&D equipment and instruments to their manufacturers’ specification.
- To maintain equipment calibration, status, and maintenance schedules
- Responsible for proper instrument implementation, testing, and validation.
- Responsible for proper maintenance and care of commercial analytical instruments in a chemistry and biochemistry laboratory.
- To support and maintain equipment inventory levels as needed to sustain both R&D and manufacturing environments (such as gases, water, and DI tanks).
- Should have good facilitation, communication, self-discipline, teamwork, and task organizational skills
- To document Equipment and Engineering activities in accordance to established procedures, company policies, FDA, and other regulatory requirements.
- To apply electronic/mechanical knowledge and skills to assist with continued development of efficient Engineering practices.
- To maintain tests equipment, fixtures, and tooling needed to support manufacturing and R&D company needs
Supervisory Responsibilities:
As need
Qualifications: 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 analyze and troubleshoot both mechanical and electronic systems.
- Knowledge and experienced with laboratory diagnostic instrument software and systems.
- Experience using documents and quality control procedures Which include best practices
- Must have experience in the medical device, and/or biotechnology industries, preferably directly involved in commercial diagnostics product development.
- Knowledge of chemistry or biochemistry would be beneficial.
- Familiarity with common chemistry analytical instrumentation such as capillary electrophoresis instruments (CE) and UV-Vis spectrophotometers a plus.
- Familiarity with industry standards for electronic design and safety such as ASME, IEEE, UL, CSA, CE and others would be helpful but not required.
Education:
Individual must have at least a High School Diploma or equivalent.
Experience:
At least five years experience safely sustaining instruments related to manufacturing and R&D environments. Direct hands-on experience in maintaining general laboratory and electro-mechanical equipment. Must have a working knowledge of laboratory type instruments and the systems used within that environment. Must have experience with safe handling of compressed gases, treated water systems such as DI tanks, and have worked within a clean-room or laboratory environment. Knowledge of CGMP, FDA 21 CFR-Part 820 would be beneficial.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with high school level or higher education
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations: Any are a plus
Physical Demands: 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, and laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 50 pounds. Work 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.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this type of 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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