Validation Technician I/II

Genezen•Lexington, MA

20h•$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. 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 The incumbent is responsible for assisting the Validation manager in completion of all project milestones. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, process validation, and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments). Duties require some knowledge in the pharma/biotech field. This position is onsite 5 days per week in our Lexington, MA office

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.

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.
Familiarity with GE Kaye Validator and/or lives data acquisition systems.
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.
Adaptability required as work schedule may change based on business needs
Other duties as assigned