Tech Stack

Description

You will assist in completing project milestones for equipment and process validation in a gene therapy company. Responsibilities include executing qualifications, generating protocols, and collaborating with cross-functional teams to meet regulatory requirements. This role is onsite 5 days per week in Lexington, MA.

Requirements

• AS degree or certificate in science/technical field or technical trade school (desired)
• 1+ years of relevant experience in a regulated environment (cGMP preferred)
• Excellent oral and written communication skills
• Superior attention to detail and ability to multi-task
• Experience with metrology/calibration principles

Responsibilities

• Perform hands-on execution of site re-qualifications on equipment, utilities, controlled temperature units, and media fills
• 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
• Collaborate with Manufacturing, Facilities, Supply Chain, Quality Control, and Quality Assurance teams