This role will provide equipment lifecycle management support to the QC Laboratory. Primary responsibilities will include routine and corrective maintenance activities, equipment troubleshooting, qualification and decommissioning of equipment, and maintaining equipment records in electronic protocol and calibration management systems. The position requires an understanding of quality systems and principles, attention to detail, strong organizational skills, along with an understanding of analytical/microbiological laboratory equipment, knowledge of laboratory methods, and an understanding of equipment intended use and failure modes effects. High-quality skills to include: microbiological equipment troubleshooting, ability to prioritize, written and verbal communication, decision making, interpersonal skills, computer applications, problem solving.

Key Objectives/Deliverables

• :This position requires an understanding of microbiological laboratory equipment, such as isolators, incubators, and autoclaves
• .Knowledge of lab methods to understand intended use of equipment and their failure modes
• .Assist in the selection, implementation, maintenance and continuous improvement of equipment within the QC laboratory
• .Identify compliance and data integrity issues related to QC equipment and implement effective resolutions
• .Provide support, troubleshooting and maintenance of QC equipment
• .Act as a liaison between facilities/maintenance groups and laboratory personnel to schedule preventative and corrective maintenance of equipment
• .Provides post implementation support for equipment
• .Author and manage change controls and deviations related to QC Equipment
• .Ability to multitask, prioritize and coordinate work to meet customers' needs
• .Demonstrate problem solving and investigative skills
• .Ability to make decisions based on knowledge, experience, best practices and requirements
• .Ability to work independently and accurately with minimal direction
• .Escorts and oversees instrumentation/equipment service providers while on site performing instrument maintenance/qualification activities
• .Supports the establishment and maintenance of the validated state of sterility isolators, autoclaves, parts washer, controlled temperature unit systems in the laboratory
• .Assist in improvement of quality systems by creating or revising worksheets, developing, or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation system

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Requirements (Education, Experience, Training

• ):Bachelor's degree in a scientific field related to the laboratory (e.g. chemistry, microbiology or biology) with 3-5 years experience with equipment metrology. Or Associate's Degree with 5+ years with equipment metrolog
• y.Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment positio

n.
Preferred attributes but not requir

• ed:Understanding of quality principles and regulatory requiremen
• ts.Proficient with the operation of microbial laboratory equipment to include sterility isolator, autoclave, controlled temperature units, and parts wash
• er.Experience in handling quality deviations, impact assessments, root cause analys
• is.Previous experience in a GMP regulated environme
• nt.Understanding of laboratory equipment qualificat
• ionDemonstrating strong oral, written communication and interpersonal interaction skil
• ls.Demonstrated proficiency in analytical equipment maintenan
• ce.Proficiency with computer systems including computerized calibration management systems (E.g., Maximo, Blue Mountain RAM), chromatography systems, electronic laboratory systems (E.g., LES, LIMS, EL
• N).Ability to focus on continuous improveme

nt.
Additional Informat

• ion:Ability to work 8-hour days – Monday through Fr
• idayMay require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operati
• ons.Ability to carry cell phone off shift and respond to operational issues as requi
• red.Minimal travel requi