Validation Technician (Temp)

Genezen•Lexington, MA

1d•$27 - $38•Onsite

About The Position

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.

Requirements

AS degree or certificate in a science/technical field or a technical trade school.
1+ years of relevant experience working in a regulated (cGMP preferred) environment.
Excellent oral and written communication skills.
Superior attention to detail and ability to multi-task and prioritize assignments.
Experience with and knowledge of metrology/calibration principles.
Adaptability required as work schedule may change based on business needs
Criminal background check required

Nice To Haves

Familiarity with GE Kaye Validator and/or lives data acquisition systems.

Responsibilities

Perform hands on execution of site Re-qualifications on equipment, utilities, controlled temperature units, and Media Fills.
Support efforts in developing remediation for follow-up and emergency requalification work.
Generates validation protocols, executes protocols, completes data analysis and writes final reports.
Perform calibrations on thermocouples with data loggers in a GMP/GXP environment.
Participate in peer review and approval of validation documentation.
Works in close collaboration with Manufacturing, Facilities, Supply Chain, Quality Control, and Quality Assurance teams to complete qualification responsibilities.