About this role
Role Overview
- Act as the calibration SME within the Facilities Management Center of Excellence (CoE) to ensure calibration program effectively implemented across all manufacturing facilities.
- Establish, lead and maintain facilities management programs to ensure compliance with cGMP regulations and industry standards.
- Identify risks that could affect product quality, safety, or compliance, and develop strategies to mitigate these risks.
- Develop and implement procedures for handling deviations and investigations.
- Establish a robust system for managing FM records, ensuring audit readiness and traceability.
- Define and implement corrective and preventative actions related to facilities management including calibration issues.
- Conduct regular audits and compliance reviews to verify adherence to internal standards and regulatory requirements.
- Lead deviation management and facilitate investigations, including audits, to identify root causes.
- Analyze trends and lessons learned for continuous improvement opportunities.
Requirements
- Minimum of 6-8 years of hands-on experience in calibration management, instrumentation, or quality assurance within regulated industries such as Pharmaceuticals, Biotech, or Medical Devices.
- Consistent track record of leading calibration / maintenance programs at a global level, including establishing, maintaining, and auditing processes.
- Experience with Digital & Automated Calibration Systems: Familiarity with calibration management software, CMMS platforms, or automated calibration tools to enhance compliance and efficiency.
- Demonstrated expertise in cGMP, regulatory standards, and risk mitigation related to calibration and equipment reliability.
- Deep understanding of industry-specific standards such as FDA regulations, EMA guidelines, and international calibration standards (e.g., ISO 17025, ANSI/NCSL Z540).
- Experience acting as a Subject Matter Expert (SME) in calibration / maintenance compliance, supporting audits, and implementing continuous improvement initiatives.
- Ability to analyze learning metrics, assess ROI, and continuously improve programs based on data insights.
- Strong organizational skills to run multiple initiatives and timelines.
Benefits
- Inclusive work environment
- Professional development opportunities
- Equal opportunity employer
- Support for individuals with disabilities