Instrumentation and Calibration Engineer

Instrumentation and Calibration Engineer

The Instrumentation and Calibration Engineer is responsible for ensuring the site’s production instruments are operating at optimal levels and properly maintained in an FDA regulated environment. The position’s primary responsibilities include maintaining all instruments in a calibrated state, supporting troubleshooting of production equipment/utilities, and managing asset maintenance.

• Support the Preventive Maintenance (PM) program through creation of new PM tasks and 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 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.
• Assess and monitor equipment for reliability of operation, implementing necessary improvements.
• Maintain system classification of incoming equipment with the system owner, including 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 and train Operations personnel in Autonomous Maintenance.
• Maintain calibration records and qualification of calibration contractor.
• Manage risk to achieve organization’s strategic objectives in areas of environmental health and safety, asset capability, quality, and production.
• Conduct risk analyses routinely when production equipment is functioning outside of expected parameters.
• Develop total cost of ownership, mean time to failure, life cycle cost, mean time to repair specific to critical equipment in the production areas.
• Run process improvement projects from design through implementation, applying RCCM to develop improved preventive maintenance tasks.
• Execute changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, and closing out change controls.
• Collaborate with other departments to ensure reliability is integrated into all aspects of the organization.
• Participate 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.
• Associate’s degree in an engineering or scientific discipline and at least 5 years of experience.

• Analytical thinking: ability to think critically and logically, and work with large sets of data and make sense of them.
• Technical aptitude: strong understanding of the systems, equipment, and processes at hand, including knowledge of engineering principles and specific systems used at the organization.
• Mechanical aptitude: understanding of how mechanical components fit together and support the function of equipment, and demonstration of curiosity for how production equipment functions.
• Problem-solving: ability to think creatively and devise innovative solutions to complex problems, including specific experience applying root cause analysis concepts to determine root causes and create effective corrective actions.
• Communication: ability to explain technical concepts clearly and collaborate with others, and to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.
• Time management: ability to manage multiple projects and tasks simultaneously and effectively, including planning, scheduling, and organizing; preferred experience with Agile Project Management System.
• Continuous improvement mindset: identifying and implementing ways to continuously improve reliability.
• Lean manufacturing and Six Sigma knowledge: understanding of lean manufacturing principles and applying Six Sigma concepts to chemical manufacturing.
• Safety-consciousness: ability to identify potential hazards and take necessary steps to mitigate them.
• Knowledge of CMMS system and functions.
• Knowledge of regulations and their application to instruments that gather GMP data in a production environment.