Calibration Specialist

Job Description

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

Ensure proper maintenance, calibration, technical support, validated state, analytics and metrics for the manufacturing process and facility equipment. Coordinate and supervise 3rd party testing and calibration on electrical, mechanical, and analytical equipment for conformance to established ISO standards. Ensure all work being executed meets technical standards and functionality. Work to improve accuracy and precision in all devices that measure quantities.

ESSENTIAL JOB FUNCTIONS

Maintain a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments

Plan, schedule, and oversee 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, support, and supervise external calibration service providers

Track, report, and provide metrics using GMP Insights for monthly and quarterly calibration status of all equipment/instruments in the facility

Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.

Be administrator for Computerized Maintenance Management System (CMMS)

Develop Work Plans, oversee NCR's, review completed work in CMMS.

Work towards continuous improvement, improving equipment, processes, etc.

Work with Engineering group to qualify existing and new equipment

Assist when needed with EHS, Validation, QA, QC and Manufacturing.

Ability to change directions and job responsibilities based on client projects and needs.

Ability to work independently or as part of a group.

Willingness to do whatever it takes to get the job done right and the first time

Be responsible for responding to EMS or BMS alarms.

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 / Technical Degree

Bachelor's degree

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.

Work Environment

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

Committed to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

Solutions 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

Paid sick time

10 observed holidays + 2 floating holiday + 1 volunteer day

401(k) plan with company match up to 6% of salary, vested immediately

Share Appreciation Rights

Choice of several healthcare plans

FSA and HSA programs

Dental & vision care

Employer-paid basic term life/personal accident insurance

Voluntary disability, universal life/personal accident insurance

Accidental Death & Dismemberment (AD&D) 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 has operates two locations: one in Fishers, Indiana and the second in 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.

Full-time