Job Description

Role Overview

This position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require technical expertise and troubleshooting ability to drive effective and robust production, testing and release of product to patients. This person must be able to work 3rd shift/overnight hours.

Key Responsibilities

• Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process equipment and systems
• Utilizes knowledge and experience in plumbing, HVAC, Clean room HVAC, refrigeration, pipefitting, and millwright activities associated with the related mechanical systems, utilities, and process equipment
• Perform minor upgrades and installations of facilities and systems
• Perform on-site equipment maintenance and critical utilities maintenance operations, and compliance. This includes but is not limited to: support to manufacturing equipment projects, cost-improvement initiatives, asset management, reliability, and business operations.
• Support facility project initiatives as needed
• Maintain knowledge of and compliance to all applicable codes and regulations as required. Obtains and keeps current all required licensing and certifications associated with the job
• Possesses experience and training in reactive, preventive, and predictive maintenance of all mechanical, HVAC and refrigeration. plumbing/pipefitting areas with journeyman status in at least one
• Reads and interprets blueprints, P&IDs, and drawings
• Utilize good documentation practices (GDP) for all work performed on the CMMS system work orders. Completes all other work associated with the assignment working cooperatively with others
• Demonstrated ability to effectively troubleshoot, plan work and anticipate potential problems and take appropriate actions
• Demonstrated ability to remove defective parts by dismantling equipment; using hoists, scissor lift and manlifts, and hand and power tools
• Repair of instrumentation, electrical devices, circuits, and switchgear used in cGMP and non GMP systems
• Investigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation systems, electrical systems, controls, motors with voltages up to 600 volts
• Operate, monitor, and maintain switchgear
• Working knowledge of building automation systems, including PLC’s, HMI’s, sensors, and other components
• Familiarity working with validated and qualified equipment, and associated documentation required
• Familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory
• Ensures regulatory and job training remains current by promptly completing required training
• Complies with all company and/or site policies and procedures
• Support maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s
• Demonstrates willingness to learn new skills as required
• Available for other duties as required
• Support tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous improvement activities
• Ensure site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration
• Ability to work independently and with minimal guidance/oversight
• Ability to accommodate changes in the schedule including working in other shifts and providing on call support as per operational needs is required.
• Key Relationships: Ability to interact with all levels within the organization. Operations, Quality, HSE, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering

Requirements

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field or minimum of a High School diploma required with equivalent experience. Trade / Technical School Certification or Certification in Craft required. Military equivalent of Trade / Technical School certification
• Minimally 4+ years of experience in an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions
• Proficiency in more than one craft
• Experience in the Pharmaceuticals or related industry is preferred
• Experience working in a controlled, cleanroom environment under aseptic conditions is preferred
• Experience in HVAC and cleanroom maintenance is preferred
• Experience with CMMS or similar maintenance management system is required
• Proficiency in English (verbal and written) and strong communication skills
• cGMP manufacturing
• Maintenance, facilities and utilities
• Computerized maintenance management systems (CMMS)
• EHS and regulatory standards (e.g. EPA, OSHA and DEA)
• HVAC operation, building automation and environmental monitoring systems, process maintenance, instrumentation, automation PLCs, VFDs and electrical practices
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
• Strong analytical, problem solving and critical thinking skills
• Continuous improvement
• Excellent organizational and communication skills
• Transparent, Passionate, Fearless and Accountable
• Language: English

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