About The Position

The Calibration & Metrology Specialist is responsible for ensuring the compliance, reliability, and performance of laboratory instrumentation and associated software systems within a GMP-regulated environment. This role supports calibration, qualification, preventative maintenance, and data integrity activities across Chemistry and Microbiology laboratories. Depending on experience level, the role may range from hands-on execution of calibration activities (Junior) to leadership of the calibration function, including planning, oversight, and strategic metrology operations (Senior).

Requirements

  • Bachelor’s degree in Science, Engineering, or related field
  • 2+ years (Junior–Mid) OR 5+ years (Senior) in calibration/metrology/validation roles
  • Experience in a GMP-regulated pharmaceutical or laboratory environment (3–10+ years depending on level)
  • Experience in pharmaceutical testing or regulated laboratory operations
  • Strong understanding of GMP, cGMP, and ICH guidelines
  • Hands-on experience with laboratory instrumentation calibration and qualification
  • Familiarity with validation lifecycle (IQ/OQ/PQ)
  • Understanding of laboratory software systems and data integrity principles
  • Experience supporting audits and regulatory inspections
  • Strong troubleshooting and analytical problem-solving skills
  • Ability to work independently and within cross-functional teams
  • Excellent communication skills (written and verbal)
  • Strong organizational and time management abilities
  • Ability to perform under pressure and manage multiple priorities
  • Proactive, detail-oriented, and quality-driven mindset
  • Adaptability to new technologies and systems

Responsibilities

  • Perform calibration procedures on laboratory instruments and equipment in accordance with established protocols, industry standards, and regulatory requirements (FDA, Health Canada, ISO/IEC 17025), including HPLCs/UPLCs, GCs, Karl Fischer (KF) titrators, UV spectrophotometers, dissolution apparatus, wet chemistry analyzers, stability chambers, incubators, TOC analyzers, and related instrumentation
  • Conduct metrology assessments using precision instruments to verify equipment accuracy and functionality
  • Develop, implement, and update calibration procedures, work instructions, and schedules to enhance efficiency and maintain quality standards
  • Maintain detailed calibration records, documentation, and traceability reports to ensure regulatory compliance
  • Prepare, write, review, and execute qualification protocols (IQ/OQ/PQ) for new and modified laboratory equipment
  • Troubleshoot equipment malfunctions, coordinate repairs with external vendors, and ensure instruments remain in GMP-compliant, validated, and operational condition
  • Analyze calibration data and generate reports to identify trends, deviations, and areas for improvement
  • Perform data integrity assessments for laboratory software and systems to ensure compliance with cGMP and ICH guidelines
  • Develop, review, and maintain QA-controlled documentation related to calibration, qualification, and maintenance, including Validation Master Plans and equipment inventories
  • Respond to instrument alarms and system monitoring alerts, including off-hours support when required
  • Conduct temperature/humidity excursion investigations and prepare deviation reports
  • Operate and manage laboratory information management systems (LIMS) for calibration tracking and documentation
  • Collaborate with laboratory teams, QA, and Metrology/Engineering leadership to schedule calibration activities and minimize operational disruptions
  • Train laboratory personnel on equipment use, techniques, and compliance requirements; maintain training records and support competency development
  • Support audit readiness and participate in internal/external audits; prepare responses to audit findings and regulatory inspections
  • Lead or support change control processes for new or modified equipment
  • Lead and coordinate calibration/Metrology team activities, work schedules, and workload prioritization while maintaining hands-on involvement in complex calibration and troubleshooting activities
  • Develop strategic calibration and metrology planning initiatives, including equipment lifecycle management, preventative maintenance optimization, and resource allocation across laboratory platforms
  • Provide advanced troubleshooting expertise and technical guidance on complex instrument issues, failure analysis, and resolution strategies
  • Mentor junior staff and provide technical guidance on calibration best practices and skilled troubleshooting methodologies
  • Manage instrument budgets and lifecycle planning
  • Conduct performance reviews for direct reports
  • Drive continuous improvement initiatives within metrology systems and processes, including procedure enhancements and efficiency optimization

Benefits

  • health & dental coverage
  • life and disability insurance
  • RRSP with 3% company match
  • paid holidays
  • paid time off
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