Reliability Engineer

Reliability Engineer

Requirements

• Bachelor’s degree required in Engineering field or Life Sciences. An equivalent combination of education and experience will be considered.
• 7 years of GMP experience working within the pharmaceutical industry or other regulated industry.
• Minimum of 2 years direct Engineering experience.

Responsibilities

• Knowledge of Reliability Centered Maintenance (RCM), Computerized Maintenance Management System (CMMS), and Predictive Maintenance (PdM) technology software.
• Ability to prepare and present comprehensive reports with recommendations or needed changes.
• Ability to be effective in both a team environment and an individual contributor role.
• Knowledgeable in engineering principles related to instrumentation in a biopharmaceutical process.
• Knowledge of regulatory, environmental, and cGMP requirements along with knowledge of manufacturing facilities, utility operations, and building maintenance operations.
• Intermediate knowledge of electrical, mechanical, critical utilities such as compressed gas, HVAC systems, equipment functions, and maintenance practices.
• Knowledge of typical CAR-T Cell Therapy upstream and downstream processing and support equipment.
• Improves reliability of the systems, equipment, and operations by utilizing analytical, statistical tools and instrumentation.
• Conducts and/or reviews failure modes and effects analysis (FMEA) to ensure proper maintenance tasks and intervals are established for all equipment in the RCM program to achieve the desired reliability.
• Communicates with other departments (Manufacturing, QC, and Warehouse) to develop and meet reliability requirements to ensure strategic manufacturing goals are being met.
• Prepares presentation slides to describe the status, benefits, and opportunities within RCM based recommendations and/or solutions.
• Performs root cause failure analysis (RCFA) for chronic or critical equipment failures and identifies corrective actions necessary to increase future reliability.
• Reviews maintenance equipment history to provide proactive solutions to potential problems affecting reliability and/or cost.
• Ensures all new equipment meets or exceeds standards for reliability.
• Works directly Maintenance group to provide guidance and decision making regarding the maintenance procedures and process to ensure the reliability goals for the plant are met.
• Supports the execution of capital projects, when required. Ensures EHS and cGMP practices and regulations are considered in all activities related to the owned system, projects, maintenance, etc.
• Supports predictive maintenance initiatives.
• Provides support to other Engineering and Maintenance Department functions as required by plant needs and unplanned events.
• Develops and follows strict Standard Operating Procedures (SOP’s) to ensure quality, and that compliant maintenance activities are completed in a timely manner.
• Collaborating with cross-functional teams, assist in collecting and analyzing reliability data, equipment performance metrics, and maintenance records. This data-driven approach will help identify patterns, trends, and areas for improvement in the reliability of our processes.
• Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Familiarity with FDA / cGxP environments and associated compliance regulations.

Preferred Qualifications

• 1-2 years of experience with cell and gene therapy.
• Operational Excellence.
• Reliability Engineering experience.