Job Title: Calibration Engineer
Location: New Jersey
Duration: Longterm
Job Summary:
The Calibration Engineer is responsible for managing and executing calibration activities for GMP manufacturing, laboratory, and utility equipment within a pharmaceutical manufacturing environment. This role ensures that all instruments and equipment are calibrated, maintained, documented, and controlled in compliance with approved SOPs, cGMP guidelines, FDA requirements, data integrity standards, and site quality systems.
The Calibration Engineer supports manufacturing reliability, product quality, audit readiness, and regulatory compliance by maintaining accurate calibration records, investigating out-of-tolerance events, coordinating with cross-functional teams, and ensuring all calibration activities are completed within the defined schedule.
Key Responsibilities:
- Execute routine and non-routine calibration activities for GMP manufacturing, laboratory, packaging, and utility equipment.
- Perform calibration of instruments such as pressure gauges, temperature sensors, RTDs, thermocouples, flow meters, level transmitters, pH meters, conductivity meters, balances, weighing systems, autoclaves, incubators, and analytical instruments.
- Maintain calibration records, certificates, equipment history files, logbooks, calibration due-date reports, and other GMP documentation.
- Review, revise, and follow calibration SOPs, work instructions, calibration procedures, and preventive maintenance procedures.
- Investigate out-of-tolerance calibration results and support product-impact assessments, deviation investigations, CAPA, and change control activities.
- Coordinate with QA, QC, Production, Validation, Engineering, Maintenance, and external calibration vendors to ensure timely completion of calibration tasks.
- Support internal audits, regulatory inspections, and client audits by ensuring calibration documentation is accurate, complete, and audit-ready.
- Maintain and update calibration schedules in CMMS or calibration management systems such as SAP PM, Maximo, Blue Mountain RAM, ProCal, or Beamex.
- Support qualification, onboarding, and lifecycle management of new instruments and equipment.
- Identify opportunities to improve calibration processes, reduce overdue calibrations, improve documentation accuracy, and strengthen compliance.
- Ensure all calibration activities are performed according to GMP, GDP, data integrity, safety, and site quality requirements.
Skills Required:
- Strong knowledge of calibration, instrumentation, metrology, measurement principles, and equipment troubleshooting.
- Hands-on experience with pressure, temperature, flow, level, pH, conductivity, weighing, and analytical instruments.
- Good understanding of GMP, GDP, FDA 21 CFR Part 211, SOPs, deviation management, CAPA, change control, and audit readiness.
- Experience working with CMMS or calibration management systems such as SAP PM, Maximo, Blue Mountain RAM, ProCal, Beamex, or similar tools.
- Ability to review calibration certificates, identify out-of-tolerance conditions, and support technical investigations.
- Strong documentation skills with attention to accuracy, completeness, and compliance.
- Ability to work cross-functionally with QA, QC, Manufacturing, Validation, Engineering, Maintenance, and vendors.
- Basic knowledge of preventive maintenance, equipment lifecycle, validation, and data integrity requirements.
- Strong problem-solving, communication, planning, and organizational skills.
- Ability to work in a regulated pharmaceutical manufacturing environment while following safety and quality standards.
For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.