Calibration Specialist

Calibration Specialist-St Louis, MOPosition SummaryThe 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 ResponsibilitiesCalibration 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.QualificationsEducation & 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).