Specialist I​/II​/III, Calibration

Specialist I/II/III, Calibration

Indianapolis, IN

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

Provide maintenance, calibration, and technical support to the manufacturing process and facility equipment. Coordinate and perform testing and calibration on electrical, mechanical, and analytical equipment for conformance to established standards. Request purchase order requisitions for 3rd party maintenance requirements.

• Assist in creating/establishing a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments
• Plan, schedule, and perform planned and unplanned maintenance and calibration on process and facility equipment/utilities including but not limited to HVAC, freezers, cold rooms, bioreactors, filling systems, analytical testing instruments, and building management control systems
• Coordinate and support external calibration service providers
• Build relationships with customers, colleagues, and service partners to provide a collaborative approach to the operational management of lab spaces.
• Track and report on calibration status of all equipment/instruments in the facility
• Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.
• Obtain required documentation and approval prior to creation of purchase order requisition for service requests to be completed by 3rd party vendors.
• After purchase order has been issued, ensure service delivery dates are correct and revise as necessary, per follow-up with suppliers and customers.
• Source, qualify, negotiate, and procure service contracts in support of lab operations.
• Ensure purchase requisitions are requisitions closed within 180 days and confirm that associated purchase orders are closed as well.
• Enter and maintain records in the Computerized Maintenance Management System (CMMS)
• Meet regularly with key stakeholders (lab staff, service partners, management) to identify, review and resolve issues in a timely manner and/or escalate as necessary.
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

• Associates Degree
• Bachelor's degree
• EET
• 3-5 years related Calibration/Metrology work experience
• Ability to understand user manuals/specifications, wiring diagrams, equipment Piping & Instrumentation Diagrams (P&), and Standard Operating Procedures (SOP)
• Mechanically inclined/knowledge of hand tools
• Proficient with advanced computer systems including the use of a CMMS
• Excellent interpersonal skills and communication skills with ability to act as a change agent

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.

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the…