GMP Validation Technician - Onsite in Lexington, MA

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.

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.

Position is onsite 5 days per week in our Lexington, MA office.

• 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.
• Generate validation protocols, execute protocols, complete data analysis and write final reports.
• Perform calibrations on thermocouples with data loggers in a GMP/GXP environment.
• Participate in peer review and approval of validation documentation.
• Work 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.
• Criminal background check required.
• Other duties as assigned.

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.

Hourly compensation range: $27/hr - $38/hr this is a temporary position that will be payrolled through a third‑party staffing company.

Regularly sit for long periods of time.

• Frequently required to stand, sit, use hands to finger, handle or feed; 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.

• Frequently required to communicate by talking, hearing, using telephone, and e‑mail.

• Paid vacation days, amount based on tenure.
• 401(k) plan with company match up to 6% of salary, vested immediately.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Employer‑paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.

• 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 operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.