Genezen
gene therapy
ValidationTechnician(Temp)
Neural analysis suggests this role is
optimal for Entry candidates.
“Validation Technician (Temp) at Genezen. Skills: validation, qualification, documentation, calibration. Assisting the Validation manager in completion of all project milestones. Installation, operational and performance qualification of equipment and utilities”
What You'll Achieve.
meet regulatory requirements for new and existing products
Industry & Context.
collaborative problem solvers; data-driven decisions
onsite 5 days per week, work schedule may change based on business needs, Criminal background check required, Regularly sit for long periods of time, Frequently required to stand, sit, use hands to finger, handle or reach with hands and arms, Occasionally required to walk, climb or balance, and stoop, kneel, crouch or crawl, Frequently lift and/or move up to 10 pounds, Rarely lift and/or move up to 40 pounds, Frequently utilize close vision and the ability to adjust focus
What They're Looking For.
Must Have
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
Nice to Have
AS degree or certificate in a science/technical field or a technical trade school
What You'll Do.
Assisting the Validation manager in completion of all project milestones
operational and performance qualification of equipment and utilities
Environmental qualification
Preparation of all relevant documentation to meet regulatory requirements for new and existing products
Perform hands on execution of site Re-Qualifications on equipment
controlled temperature units
Support efforts in developing remediation for follow-up and emergency requalification work
Generates validation 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
How You'll Work.
Team & Collaboration
Works in close collaboration with Manufacturing, Facilities, Supply Chain, Quality Control, and Quality Assurance teams to complete qualification responsibilities
Communication Scope
Excellent oral and written communication skills; communicate by talking, hearing, using telephone, and e-mail
Process & Methodology
completion of all project milestones
Full 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 The Validation Technician will be 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 JOB 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 collabora
Applying for this Validation Technician (Temp) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Genezen?
Real rants from real employees. Read before you apply.