Job description

Summary

Center for Breakthrough Medicines is an innovative cell and gene therapy focused contract development and manufacturing organization located in the heart of “Cellicon Valley.” CBM’s integrated and comprehensive service offering provides a one-source solution to accelerate speed to market for advanced therapies.

A client-driven approach coupled with a patient-centric culture delivers high quality and reliable process and analytical development, viral vector manufacturing, GMP testing, cell therapy bioprocessing, plasmid production, and cell banking services for a full product’s life cycle.

Responsibilities

• Responsible for the daily support of building infrastructure and systems
• Supports the Facility team engaged in maintaining building infrastructure, services, security, and grounds
• Monitors work order system and executes
• Works with the Engineering team to plan and implement equipment, systems and facilities modifications
• Create and maintain relationships within CFBM to develop and promote best practices and ensures compliance with SOP’s, safe work practices, and cGMP regulations
• Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities
• Coordinates support from site facilities manager for infrastructure and core utilities

Qualifications

• 5+ years of experience in a GMP facilities/manufacturing environment
• 2+ years of experience in a functional maintenance or calibration leadership role
• Direct experience supporting building facilities and utility systems within a manufacturing/production environment is desirable
• Understanding of local and state regulations and permitting
• Experience with the following unit operations or technologies: HVAC design and operations, electrical distribution, compressed gases, clean utilities (steam & WFI), Building Management Systems (BMS)
• Extensive knowledge in all disciplines of construction, especially GMP utility and cleanroom design/installation and quality control laboratory design/installation
• Strong understanding of industry standards for equipment qualification, maintenance, calibration, and operation of facilities and utilities for cGMP manufacturing and GXP laboratories
• Strong interpersonal and communications skills; written and oral
• Previous proficient experience with CMMS software system(s)
• Knowledge of OSHA and EPA regulations

#IND1

Job Type: Full-time

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• King of Prussia, PA 19406: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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