Specialist I/II/III, Calibration

Overview 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. Working at Genezen 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. Job Summary 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 third-party maintenance requirements. Essential Job Functions 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 third-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 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 Knowledge, Skills and Experience Associates Degree EET 3-5 years related Calibration/Metrology work experience Ability to understand user manuals/specifications, wiring diagrams, equipment Piping & Instrumentation Diagrams (P&ID), 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 Physical Demands 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 floor during activity execution (maintenance, construction, commissioning and qualification) is required Movement Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 10 pounds Occasionally lift and/or move up to 25 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail Genezen's Cures Value-Based Competencies C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. U rgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners\' programs. R esilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. E xecute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principles. S olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. Genezen's Benefits Paid vacation days, amount based on tenure 401(k) plan with company match up to 6% of salary, vested immediately Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Additional Details Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen operates two locations: Fishers, Indiana and Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum—to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride. Create a Job Alert Interested in building your career at Genezen? Get future opportunities sent straight to your email. 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