Job Description
Perform IQ.OQ/PQ of new laboratory equipment
Perform routine preventive maintenance and calibration of laboratory equipment
Repair and maintain laboratory instrumentation in a cGMP qualified state
Manage laboratory maintenance and calibration schedule
Coordinate maintenance and calibration events with Laboratory Operations
Assure lab equipment is available to lab operations to meet client testing needs.
Perform uniformity mapping of controlled storage chamber, refrigerators and freezers.
Perform investigations of failing calibration results
Mentor/train analysts on equipment operation and routine maintenance
Coordinate subcontracted maintenance and calibration services
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Serve as Subject Matter Expert for multiple laboratory equipment platforms
Work with computer system validation engineers to qualify lab equipment with software driven applications.
Education and Experience:
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science. >1 year experience with laboratory equipment operation, maintenance and/or repair.
High School Diploma or GED, with 3-5 years related experience in equipment operation, maintenance and/or repair.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
Strong knowledge of varied aspects or a specialized aspect of a discipline. Good knowledge of scientific methodology as related to the pharmaceutical industry. Good knowledge of Good Manufacturing Practices. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients. Ability to work on multiple projects simultaneously. Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Ability to develop technical solutions.