Location: Onsite for initial project Audit/GAP Analysis and Remote for summary reports with periodic on-site travel (as required). Duration: Approximately 6 weeks (potential for extension) Client: Confidential Pharmaceutical / Medical Device Company Position Summary VTI Life Sciences is seeking an experienced Senior Metrology or Calibration Specialist to support a comprehensive Quality Control (QC) and Equipment Metrology Program assessment for a regulated pharmaceutical and medical device manufacturing facility. The successful candidate will evaluate the overall health of the metrology program by validating approximately 600 metrology assets and associated records, identifying compliance gaps, assessing instrument performance risks, and recommending improvements to strengthen regulatory compliance and audit readiness. In addition to the assessment, the candidate will provide technical support for equipment decommissioning, installation, calibration, and integration of critical laboratory and manufacturing equipment into the site's metrology program. Key Responsibilities - Perform a comprehensive assessment of the site's Metrology Program. - Review and validate approximately 600 metrology assets, including laboratory instruments, timers, thermometers, balances, gauges, pressure and temperature devices, and other calibrated equipment. - Evaluate calibration records, maintenance history, asset identification, calibration intervals, traceability, and documentation for compliance with GMP and internal procedures. - Assess metrology program effectiveness, identify gaps, and recommend corrective and preventive actions (CAPAs). - Evaluate known instrument performance risks and recommend improvements to increase equipment reliability and audit readiness. - Support equipment decommissioning activities, ensuring proper documentation, asset disposition, and quality system compliance. - Provide technical oversight for installation, calibration, and commissioning support of critical laboratory and process equipment. - Review calibration procedures and recommend improvements where appropriate. - Verify traceability to NIST (or equivalent national standards), uncertainty considerations, and calibration best practices. - Prepare detailed assessment reports, observations, risk assessments, and executive summaries. - Collaborate with Quality Assurance, Engineering, Validation, Manufacturing, and Laboratory personnel to resolve metrology issues. - Support regulatory inspection readiness and internal audit preparation. Required Qualifications - Bachelor's or Associate (certification) degree in Engineering, Physics, Metrology, Instrumentation, Engineering Technology, or a related scientific discipline. - Minimum 7 years of metrology, calibration, or instrumentation experience in FDA-regulated pharmaceutical, biotechnology, medical device, or life sciences industries. - Extensive knowledge of GMP requirements and calibration program management. - Strong understanding of FDA 21 CFR Parts 210, 211, and 820 (QMSR), ISO 13485, ISO/IEC 17025, and applicable industry standards. - Experience assessing large calibration programs involving hundreds of assets. - Plus if experience with computerized calibration management systems (e.g., Blue Mountain RAM, Beamex CMX, IndySoft, GAGEtrak, Maximo, SAP PM, or equivalent). - Strong understanding of calibration uncertainty, traceability, and measurement science. - Excellent technical writing, documentation, and communication skills. Preferred Qualifications - ASQ Certified Calibration Technician (CCT) or equivalent certification. - Experience supporting FDA inspections and regulatory audits. - Experience performing gap assessments and remediation projects. - Familiarity with commissioning, qualification (IQ/OQ/PQ), and equipment lifecycle management. - Experience with laboratory and manufacturing instrumentation in pharmaceutical or medical device facilities. Deliverables - Comprehensive QC Metrology Program Assessment Report. - Asset-by-asset validation summary and compliance review. - Gap assessment with risk ranking and recommended corrective actions. - Equipment decommissioning documentation support. - Installation and calibration support for critical equipment. - Executive summary with prioritized recommendations to improve compliance, reliability, and audit readiness. Desired Skills - Strong analytical and problem-solving abilities. - Excellent organizational and project management skills. - Ability to work independently with minimal supervision. - Strong interpersonal skills with the ability to communicate effectively with cross-functional teams and client stakeholders. - Ability to prioritize multiple tasks while meeting aggressive project timelines.