Calibration Specialist

Calibration Specialist-St Louis, MO

Position Summary

The Calibration Specialist is responsible for performing, documenting, and maintaining instrument calibrations to ensure compliance with regulatory standards and operational excellence in a pharmaceutical manufacturing environment. This role supports product quality, equipment reliability, and regulatory readiness through precise calibration practices and adherence to cGMP requirements.

Key Responsibilities

• Calibration ExecutionPerform routine and complex calibrations on temperature, pressure, flow, and analytical instruments (including pH and conductivity).
• Ensure all equipment operates within specified tolerances to maintain process accuracy and reliability.
• Regulatory Compliance (cGMP)Maintain strict adherence to Current Good Manufacturing Practices (cGMP) and site-specific Standard Operating Procedures (SOPs).
• Ensure all calibration activities meet internal and external regulatory requirements.
• Documentation & Data IntegrityAccurately complete calibration records in compliance with ALCOA+ data integrity standards.
• Maintain clear, complete, and audit-ready documentation for all calibration activities.
• NIST TraceabilityEnsure all calibration standards and master test equipment are properly certified and traceable to NIST.
• Monitor and maintain calibration status of all reference standards.
• Out-of-Tolerance (OOT) InvestigationsSupport investigations related to out-of-tolerance conditions.
• Assess potential impact of instrumentation issues on product quality and manufacturing processes.
• Calibration Management Systems (CCMS)Utilize systems such as Blue Mountain or Maximo to manage calibration schedules, records, and asset histories.
• Ensure timely completion of scheduled calibrations and system updates.
• Troubleshooting & MaintenanceDiagnose, repair, and resolve instrumentation issues to minimize downtime.
• Support high-speed and sterile manufacturing operations with rapid response to equipment failures.
• Audit & Inspection SupportProvide technical expertise during internal audits and regulatory inspections (e.g., FDA).
• Present documentation and explain calibration processes as required.
• Safety & Cleanroom ComplianceFollow all safety procedures, including Lockout/Tagout (LOTO).
• Comply with aseptic gowning and cleanroom protocols.
• Vendor & Contractor OversightCoordinate and oversee third-party calibration vendors.
• Ensure contractor work meets company quality, safety, and compliance standards.

Qualifications

• Education & ExperienceAssociate’s or Bachelor’s degree in Engineering, Life Sciences, or related technical field (or equivalent experience).
• Experience in calibration within pharmaceutical, biotech, or regulated manufacturing environments preferred.
• Technical SkillsKnowledge of calibration principles for process and analytical instrumentation.
• Familiarity with cGMP regulations and FDA compliance requirements.
• Experience with calibration management software (e.g., Blue Mountain, Maximo).