Reliability Engineer

The Instrumentation and Calibration Engineer has the responsibility for ensuring the site’s production instruments are operating at optimal levels and properly maintained to data collection in an FDA regulated environment. The position will be primarily responsible for ensuring all instruments are maintained in a calibrated state. Additionally, the Engineer will support general troubleshooting of production equipment/utilities, and asset management.

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

• Support the Preventive Maintenance (PM) program through the creation of new PM tasks, evaluation of existing PMs for technical relevance to current asset problems.
• Help create Standard Operating Procedures (SOPs) for equipment operation, engineering analyses, PM and calibration tasks, that adhere to FDA and cGMP requirements.
• Support the management of the calibrations on production instruments, such as temperature sensors (RTDs/resistance thermometers), pressure sensors (electronic manometers, gauges), and other transmitters.
• Support root cause investigations to a detailed level required for an FDA regulated/cGMP environment, and translate these root causes to effective CAPAs that mitigate equipment risk.
• Assesses and monitors equipment for reliability of operation implementing necessary improvements
• Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplier operating and maintenance manuals, installation and operational qualification.
• Translate data from Root Cause Centered Maintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance.
• Maintain calibration records, and qualification of calibration contractor.
• Manages risk to achieve organization's strategic objectives in areas of environmental health and safety, asset capability, quality, and production.
• Conducts risk analyses routinely when production equipment is functioning outside of expected parameters
• Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas.
• Runs process improvement projects from design thru implementation. Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks.
• Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs
• Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization
• Participates in and execute qualification and validation of equipment and processes

• Bachelor’s degree in an engineering discipline and 3 years of experience in a related or similar field, or
• Associate’s degree in an engineering or scientific discipline and at least 5 years of experience.

• Analytical thinking: the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.
• Technical aptitude: a strong understanding of the systems, equipment, and processes s includes knowledge of the engineering principles and specific systems used at an organization.
• Mechanical aptitude: an understanding of how mechanical components fit together and support the function of equipment. Demonstrated curiosity for how production equipment functions.
• Problem-solving: the ability to think creatively and come up with innovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root causes and create…