PI Technician
PI Technician
PI Technician
Position Title: Reports To: Department: Date Revised: FLSA Status: Process Improvement Technician Director of Production Process Improvement October 2013 Non-Exempt (hourly)
Summary: The individual will be responsible for performing Production in-process testing, data entry, and present it to the Director of Production for analysis. This position will support PI Specialists on Process Improvement projects. He or she will work closely with PI Specialists, Production Manager, Production Supervisors and Production Team Leaders, to ensure testing and trials are performed according to established company standards and methodologies. Duties and Responsibilities: 1. Perform accurately, all in-process defined testing as well as other procedures necessary to support Production and Process Improvement Departments objectives to meet specified timelines with the guidance of the PI Specialists and Director of Production. 2. Conducts relevant laboratory experiments/trials in accordance with written protocol under the guidance of the Process Improvement Specialists. 3. Ensures that all resources are available to conduct experiments and trials; this includes equipment, lab supplies, and coordination of work schedules. Ensure that equipment maintenance is properly documented in a timely manner. 4. Assists PI Specialist with making Production seeds within established protocols, ensuring that documentation is accurate and timely. 5. Develop and maintain accurate and concurrent testing records, compare test results against prescribed parameters, and reports findings to the Director of Production and/or PI Specialists. 6. Assists with Clean up and Prep work includes, but is not limited to, the following: washing, wrapping and sterilizing of glassware and laboratory equipment; loading/unloading autoclaves; washing ceilings, walls, floors, furniture, fixtures and equipment; wrapping and traying of both emulsion and live virus bottles and vials. 7. Ensure the laboratory and work areas are kept clean and organized following the corresponding SOPs or company policies. 8. Occasional weekend and off-hour work may be required. 9. Other duties as assigned by the Director of Production. Competencies: 1. Performs all duties, procedures, techniques, and completes paperwork with persistent focus on quality and safety. Supports a culture of quality by encouraging co-workers to be diligent in the performance of each task, continually striving for accuracy. Participate at the direction of Director of Production to support research, Production, and/or other departments to achieve company quality objectives. 2. Understands and effectively communicates the necessity for, and the effects of, each task performed.
3. Actively contribute to a team setting with the laboratory and potentially with other work teams to increase efficiency, solve problems and improve quality. Must be a team player; fostering positive productive relationships within the department and across departmental lines. 4. Open-minded and positive in regard to change, with a focus on continual improvement. 5. Records and reports all data accurately, honestly, legibly and within specified time frames. 6. Asks applicable questions of appropriate sources and continually seeks to understand the why behind duties performed. 7. Performs duties according to established Standard Operating Procedures (SOP's) and company safety procedures. Assists with mainta ining SOPs; uses proper change control procedures when drafting or recommending updates. 8. Demonstrates initiative by pro-actively identifying issues, obstacles, opportunities, possible solutions and the next step of action. Demonstrates initiative to take on new responsibilities and assist in other laboratory areas. 9. Consistently strives to produce appropriate volume of work with high quality results. Qualifications: Bachelor of Science degree in Virology, Microbiology, Bacteriology, Biology or related field with at least one (1) year of laboratory experience required. A n Associates Degree in science with a minimum of four (4) years of laboratory experience will be considered. Advanced knowledge of virology, biotechnology and tissue culture methods will be a plus. Understanding of Good Laboratory Practices (GLP) and good aseptic technique required. Good documentation practices, as well as the ability to follow and comprehend a written procedure is a requirement. Individual must have a proven track record of working in a team environment and handling multiple tasks simultaneously and complete tasks according to deadlines and specified time frames. Must demonstrate flexibility, adaptability and initiative. Must have excellent written and oral communication skills, excellent planning and organizing skills, as well as proficiency in MS Word and Excel. Quality Management System experience desirable (ISO 9001-2008). Working knowledge of Code of Federal Regulations desired.
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