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 to collect data in an FDA regulated environment. The primary responsibility is to keep all instruments calibrated and support troubleshooting of production equipment/utilities and asset management.

• Support the Preventive Maintenance (PM) program by creating new PM tasks and evaluating existing PMs for technical relevance.
• Help create Standard Operating Procedures (SOPs) for equipment operation, engineering analyses, PM and calibration tasks, adhering to FDA and cGMP requirements.
• Manage calibrations on production instruments such as temperature sensors, pressure sensors, and other transmitters.
• Conduct root cause investigations and translate findings into corrective and preventive actions (CAPA).
• Assess and monitor equipment reliability, implementing necessary improvements.
• Maintain system classification of incoming equipment with the system owner.
• Assemble supplier operating and maintenance manuals, installation and qualification activities.
• Translate data from Root Cause Centered Maintenance (RCCM) to support the Autonomous Maintenance program and train Operations personnel.
• Maintain calibration records and qualification of calibration contractors.
• Conduct risk analyses routinely for equipment operating outside expected parameters.
• Develop Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, and Mean Time to Repair for critical equipment.
• Run process improvement projects from design through implementation.
• Apply RCCM to improve preventive maintenance tasks and execute change controls through completion.
• Collaborate with other departments to integrate reliability into all organizational aspects.
• Participate in qualification and validation of equipment and processes.

Bachelor’s degree in an engineering discipline with 3 years of related experience, OR an Associate’s degree in an engineering or scientific discipline with at least 5 years of experience.

• Analytical thinking and data interpretation.
• Technical aptitude for equipment systems and processes.
• Mechanical aptitude and understanding of component interactions.
• Curiosity for production equipment functions.
• Problem‑solving and creative solution design.
• Experience applying Root Cause Analysis and investigation.
• Clear technical communication and collaboration.
• Ability to generate work instructions for maintenance technicians.
• Time management of multiple projects.
• Familiarity with Agile Project Management System.
• Continuous improvement mindset with lean manufacturing and Six Sigma.
• Safety‑conscious and hazard mitigation.
• Knowledge of CMMS functions.
• Knowledge of regulations for instruments collecting GMP data.

PPL provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Employment decisions are based on merit, including recruitment, selection, training, promotion, compensation, and working conditions.