Career Center

Description

SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.

SUMMARY: The Equipment Calibration and Maintenance Technician position requires a variety of skills necessary for providing equipment calibration, troubleshooting and maintenance support. This position will work in conjunction with Facilities, Engineering, Manufacturing, and Quality Departments.

Raw Materials; EM; Shipping; Equipment maintenance and basic manufacturing tasks

CCHMC SALARY GRADE:6

Regulated manufacturing processing; testing and other related tasks; analyze data; equipment maintenance; record-keeping.

REPRESENTATIVE RESPONSIBILITIES

REPRESENTATIVE RESPONSIBILITIES:

• Performs routine calibration and preventive maintenance on multiple systems including refrigerators, freezers, incubators, scales, centrifuges, and other miscellaneous benchtop instruments.
• Performs Temperature Mapping Studies on temperature controlling environments such as: freezers, refrigerators, incubators, and warehouses.
• Performs equipment troubleshooting, coordinating vendor technicians while ensuring work meets internal standards and work performed is properly documented.
• Assists with onboarding new equipment and retiring obsolete equipment.
• Works closely with facility and lab personnel to ensure collaborative and timely completion of scheduled and on demand maintenance activities.
• Partners with Quality and Manufacturing for all cGMP equipment corrective maintenance and OOT investigations and documentation.
• Develops, executes, and writes SOPs and Qualification Documents (IQ/OQ/PQ).
• Provides support and training to peers to improve their abilities and increase their technical knowledge
• Demonstrates working knowledge of GMP regulations.
• Position requires clean room gowning during performance of some job duties (shoe coverings, coverall, head covering, safety glasses, gloves).
• Other related duties as assigned.

Qualifications

EDUCATION/EXPERIENCE

Required:
???Bachelor's degree in a related field
??? 0 - 2 years of work experience in a related job discipline

Preferred:

• GMP experience working in a biopharmaceutical facility or equivalent experience in a regulated industry.
• Proficient computer skills utilizing MS Office suite applications.
• Experience working within a Computerized Calibration and Maintenance Management System.
• Validation experience is a plus.

Unique Skills:

• Demonstrated mechanical aptitude with ability to analyze, investigate and solve equipment technical issues.
• Effective time management skills.