Calibration Engineer

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.

KNOWLEDGE, SKILLS AND EXPERIENCE

• Associates Degree essential, Bachelor's degree preferred,
• 3-5 years related Calibration/Metrology work experience, GMP preferred.
• Ability to understand user manuals/specifications, wiring diagrams, equipment P&ID, and standard operating procedures.
• Mechanically inclined/knowledge of hand tools
• Proficient with basic computer systems including the use of a computerized maintenance management system (CMMS)
• Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs
• Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

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.

• Ability to work in a BSL 2 with personal protective equipment.
• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
• In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
• While performing the duties of this job, the employee must be aware of potential exposure to moving mechanical parts; high, precarious places; toxic or caustic chemicals; high noise areas, and risk of electrical shock.
• A physically able individual is required who can spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).

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
• 9 observed holidays + 1 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.