Manager, Metrology

The Role: 

ElevateBio is seeking a Manager, Metrology. The successful candidate will be responsible for ensuring all GMP and non-GMP equipment calibrations are kept in compliance with applicable regulatory and business requirements to support operations at the BaseCamp Pittsburgh site.  This position requires the candidate to be detailed oriented, organized, and have a strong understanding of metrology standard practices, calibration planning and execution and experience with various instrumentation.  Key responsibilities will be establishing initial calibration requirements, building the site calibration program, onboarding and managing vendor services, building and training the calibration team, reviewing calibration documentation using Blue Mountain R4, Kneat and Veeva, and managing compliance investigations.

Here’s What You Will Do:

• Ability to perform tasks in highly regulated development and industrial pharmaceutical environment while adhering to safety and quality program policies.
• Oversee the site Metrology program, leading calibration technicians and 3^rd party vendors, while ensuring alignment with all applicable regulatory requirements.
• Develop, implement, revise and periodically review Metrology SOP’s, work instructions, and best practices to ensure accuracy, consistency, and reliability of calibration services in collaboration with cross-site counterparts via the Metrology Community of Practice.
• Responsible for procurement, use, handling, storage, calibration and inventory of calibration standards and equipment.
• Review and maintain executed records of calibrations and repairs.
• Ensure all documentation and practices meet QA and GxP requirements.
• Develop and maintain Metrology training program – establishing goals, objectives and benchmarks to evaluate staff performance.
• Ensure compliance with relevant industry standards, regulatory requirements, external regulations, guidelines, client requirements, and internal quality management system (QMS).
• Collaborate with leadership to address non-conformities and implement corrective actions.
• Perform quality functions including deviation initiation and impact assessment for Out of Tolerance events for GMP instrumentation.
• Generate and investigate associated reverse traceability reports.
• Utilize root cause analysis to implement corrective and preventive actions to prevent future deviations with the same or similar root cause(s).
• Interpret instrument performance trends to identify opportunities for process optimization.
• Identify and implement initiatives for continuous improvement of process, quality, safety and efficiency.
• Manage vendors and contractors supporting ongoing 24/7 operations as well as future projects.
• Coordinate and schedule calibration services with business units to support ongoing operations. 

Desired Education, Experience & Skills:

• 5+ years in the field of Metrology with 3+ years in the pharmaceutical GMP industry.
• 2+ years in a supervisory Metrology role.
• Must be able to prioritize a diverse workload while applying creative problem solving.
• Experience in developing and using measurement uncertainty is highly desired.
• Experience in calibrating process, laboratory, packaging, and utility systems instrumentation/equipment in a GMP environment is highly desired.
• Experience with CMMS Blue Mountain RAM, Validation Tool Kneat and QMS Veeva is preferred.

Working Environment

• Must be capable of working in controlled clean room environments, adhering to special gowning requirements. This includes wearing protective clothing covering the head, face, hands, feet, and body, along with personal protective equipment as per safety protocols.