Associate Laboratory Operations

Responsibilities

• Support Operations and Facility management for both R&D and GMP environments.
• Provide on-the-floor support to GMP lab users.
• Execute all assigned activities in a cGMP-compliant manner in accordance with site SOPs, Good Documentation Practices, and ALCOA+ data integrity expectations, including right-first-time completion of GMP records and timely escalation of discrepancies.
• Support Lab Operations computerized maintenance management system (CMMS) functions included, but not limited to: 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.
• Review CMMS master data accuracy, including asset records, equipment hierarchy and location, criticality and GxP designation, PM and calibration job plans, recurrence patterns, calibration loop criticality assessments (LCAs), and spare parts linkage.
• Execute the full work order lifecycle in the CMMS – service request intake, scheduled and on-demand work order creation, routing, status control, failure and coding accuracy, and closeout review – in compliance with site procedures.
• Support KPI tracking through monitoring and reporting of CMMS metrics including PM compliance, overdue calibrations, work order backlog, and out-of-tolerance (OOT) events; escalate risks to Lab Operations and Engineering & Facilities leadership.
• Provide CMMS data, documentation, and transaction history in support of audits, regulatory inspections, deviations, and CAPA investigations; Support management of Engineering Turnover Packages through creation, review, and approval of documents; ensuring they are loaded and current in CMMS and the Engineering Document Management System (EDMS).
• Authoring, reviewing, and updating SOPs and WIs as assigned.
• Completion of quality events such as CAPAs, change actions, change controls, investigative actions, deviations, and impact assessments as assigned.
• Partner with Lab Operations, Validation, Quality, and Engineering & Facilities (Maintenance, Metrology, and Automation), on equipment selection, installation, start-up, troubleshooting, and lifecycle decisions for laboratory and GMP support equipment.
• Support commissioning and qualification activities (URS input, FAT/SAT, IQ/OQ/PQ protocol execution and data review) and support requalification and periodic review of GMP laboratory equipment.
• Support root cause analysis for equipment-related deviations, OOT/OOS calibration results, and repeat failures; contribute technical input to CAPA and effectiveness checks.
• Partner and Collaborate with multiple onsite support vendors.
• Help enforce Beam's safety policies and good work practices.
• Participates in emergency on-call rotation as required to support operations.
• Identifying and optimizing workflows.
• Other support tasks as required.

Qualifications

• AS or BS in a life science or other relevant scientific discipline preferred.
• Working knowledge of cGMP regulatory requirements applicable to equipment and laboratory operations, 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, and to communicate technical issues effectively with Tech Ops personnel.
• Experience working in classified lab / cleanroom spaces, and familiarity with an EDMS (Accruent Meridian or equivalent), preferred.
• Experience with Blue Mountain RAM or another CMMS, as well as BSL-2 tissue culture experience, is required.
• Experience with Veeva or another QMS and calibrating process, laboratory, packaging, and utility systems instrumentation/equipment in a GMP environment preferred.
• Knowledge of biohazard regulations and material handling, including general industry and laboratory-specific safety standards, preferred.
• Customer-oriented with strong prioritization and multitasking skills, with the ability to manage multiple tasks and stakeholders while maintaining professionalism.
• Enthusiastic learner with strong attention to detail, personal responsibility, maturity, and a strong work ethic.
• Ability to work independently and collaboratively, communicate openly and directly, and demonstrate a team-oriented and professional approach.