Engineer - Reliability

Reliability Engineer plays a key role in establishing maintenance and reliability strategy for the department. As a key member within the Maintenance department, this position is directly accountable for ensuring equipment / process up time to be better than the target through management of key metrics (MTTR, MTBF, OBE, OEE) and continuous improvement. The position will support Reliability Engineering initiatives across various departments pe of the role may support Device Assembly & Packaging, Parenteral manufacturing area which includes aseptic formulation, equipment preparation, filling and Visual inspection departments and Critical Utilities for the site.

This is a hands‑on role where the engineer may be required to perform troubleshooting of equipment, root cause analysis, component and system analyses to identify reliability improvements and reduce risks, recommend/execute design modifications and/or various reliability improvement strategies.

• Follow safety rules and help improve safety culture.
• Act as technical POC (point of contact) for Maintenance technicians, operations and Engineering for resolving day‑to‑day production issues and for other medium/ long‑term equipment reliability concerns.
• Collect data and report on equipment/ process efficiency metrics (OBE, OEE, OA, MTTR, MTBF) on an ongoing basis.
• Lead all initiatives for equipment/ process uptime – including data collection, analysis, coordinating with x‑functional team, identifying parts, parameter changes, etc, all the way thru implementing the change (with appropriate documentation and approvals).
• Works with maintenance and Engineering technicians to review and update any job plans, Work instructions to perform/ complete PMs’ and CMs’ efficiently (frequency, method).
• Employ a hands‑on approach with problem solving independently or through facilitation with other engineers, technicians, crafts people, and operators. This may include tearing down failed machine tool components such as motors, pumps, gearboxes, valves, etc.
• Understand the manufacturing equipment and processes and the impact of equipment performance within the manufacturing system.
• Prepare necessary training material and conduct training for Maintenance technicians, Engineering technicians as necessary.
• Promote proper use of the CMMS system and ALCOA+ principles for developing maintenance strategies, maintenance execution, and documenting equipment history.
• Supports Process Engineering spare parts identification and stocking strategy.
• Supports Process/ Utility Engineers in determining causes of performance degradation of equipment as required.
• Utilize appropriate techniques and tools (RCA, RCM analysis, failure analysis, etc.) to investigate and reduce equipment‑related deviations and downtime.
• Lead and/or support deviation investigations.
• Seek and implement new technologies to enhance equipment performance and availability.

• Bachelor’s degree in engineering or related technical field.
• 6 years’ experience in a regulated industry.

• Experience in using and directing the use of FMEA and RCA processes.
• Demonstrated ability to work independently without close supervision.
• Adequate interpersonal and communications skills to be able to work effectively in a team‑based environment.
• Strong computer skills in a variety of software packages (Microsoft Office, etc.).
• Ability to work in a safe manner to ensure the safety of self and others.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ability to troubleshoot equipment or process problems.
• Knowledge of automation systems/software to facilitate data collection.
• Working knowledge of vision systems (Cognex, Keyence) to create, modify, edit tools, etc.
• Working knowledge of FDA Regulations including cGMP.
• Working knowledge of ISO standards, IEC standards and industry best practices.
• Working knowledge of Preventive and Predictive Maintenance techniques, including but not limited to Tribology, Vibration Analysis, Thermography, Life Cycle Cost Analysis, equipment installation requirements, etc.
• Experience/working knowledge of…