Calibration Specialist

Job Title: Calibration Specialist

Work Location: St. Louis County, Missouri

Summary:

The Calibration Specialist is responsible for executing, documenting, and maintaining calibrations of various instruments to ensure compliance with regulatory standards and operational excellence in a regulated manufacturing environment. This role is essential for supporting product quality, equipment reliability, and regulatory readiness through precise calibration practices and adherence to industry requirements.

Responsibilities:

• Conduct calibrations on a range of instruments, including temperature, pressure, flow, pH, and conductivity devices, ensuring all equipment operates within specified tolerances.
• Maintain compliance with current Good Manufacturing Practices (cGMP) and Standard Operating Procedures, ensuring all calibration activities meet regulatory requirements.
• Accurately document calibration activities, maintaining audit-ready records in line with ALCOA+ data integrity standards.
• Ensure all calibration standards and master test equipment are certified and traceable to NIST, and monitor the calibration status of reference standards.
• Support investigations into out-of-tolerance conditions and assess the impact of instrumentation issues on product quality and processes.
• Utilize calibration management systems to manage schedules, records, and asset histories, ensuring timely completion of calibrations and updates.
• Diagnose and resolve instrumentation issues to minimize downtime, supporting manufacturing operations with rapid response to equipment failures.
• Provide technical expertise during audits and inspections, present documentation, and explain calibration processes as needed.

Qualifications:

• Associate’s or Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent experience.
• Experience in calibration within pharmaceutical, biotech, or regulated manufacturing environments preferred.
• Knowledge of calibration principles for process and analytical instrumentation.
• Familiarity with cGMP regulations and FDA compliance requirements.
• Experience with calibration management software such as Blue Mountain or Maximo.
• Ability to follow safety procedures, including Lockout/Tagout (LOTO), and comply with cleanroom protocols.
• Strong documentation skills and attention to data integrity standards.
• Ability to coordinate and oversee third-party calibration vendors, ensuring quality and compliance.

Published Category: Manufacturing & Technical Operations