Associate Laboratory Operations

The role

This role supports lab operations and facility management for R&D and GMP environments. The person will act as a data steward for the site Computerized Maintenance Management System and execute activities in accordance with cGMP and data integrity principles.

What you will do

• Support Operations and Facility management for R&D and GMP environments
• Provide on-the-floor support to GMP lab users
• Execute activities in a cGMP-compliant manner following site SOPs and ALCOA+ principles
• Manage or support onsite assets including inventory, enrollment, and validation
• Coordinate and support 3rd party contracted services to repair, calibrate, PM and qualify equipment
• Review and ensure accuracy of all calibration, service and repair documentation and records
• Execute the full work order lifecycle in the CMMS
• Support KPI tracking through monitoring and reporting of CMMS metrics
• Provide CMMS data and documentation in support of audits, regulatory inspections, deviations, and CAPA investigations
• Support commissioning and qualification activities

Required qualifications

• 0-2+ years of experience
• Working knowledge of cGMP regulatory requirements including 21 CFR Parts 210/211 and Part 11, EU GMP Annex 1 and Annex 11, and ALCOA+ data integrity principles
• Ability to interpret equipment drawings, P&IDs, utility schematics, and vendor manuals
• Experience with Blue Mountain RAM or another CMMS
• BSL-2 tissue culture experience
• Customer-oriented with strong prioritization and multitasking skills
• Enthusiastic learner with strong attention to detail, personal responsibility, maturity, and a strong work ethic
• Ability to work independently and collaboratively

Nice to have

• AS or BS in a life science or other relevant scientific discipline
• Experience working in classified lab / cleanroom spaces
• Familiarity with an EDMS (Accruent Meridian or equivalent)
• Experience with Veeva or another QMS
• Experience calibrating process, laboratory, packaging, and utility systems instrumentation/equipment in a GMP environment
• Knowledge of biohazard regulations and material handling, including general industry and laboratory-specific safety standards

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.