Facilities Cross Functional Technician (Metrology, Calibrations, and Quality Systems)

AstraZeneca•Durham, NC

25d

About The Position

Leads the site’s metrology and equipment implementation program across analytical, manufacturing, facilities, and safety equipment. Manages end-to-end deployment, qualification, calibration, maintenance, troubleshooting, scheduling, and workflow. Drafts and maintains maintenance, operation, and calibration documentation to meet business and regulatory needs. Provides expert guidance on asset management systems and ensures inspection readiness in a GMP environment.

Requirements

BS in Science or Engineering with 5+ years relevant GMP pharmaceutical experience (or 5+ years pharmaceutical experience).
Metrology experience with analytical, manufacturing, process, facilities, and safety equipment.
Experience in analytical equipment qualification and lifecycle (IQ/OQ/PQ/periodic review).
Expertise with asset management/CMMS software in the pharmaceutical industry.
Technical ability to troubleshoot and maintain equipment such as balances, chart recorders, and stability chambers.
Indepth understanding of ICH, USP, EP, FDA guidance and cGXPs supporting metrology in a manufacturing setting.

Nice To Haves

Experience with change control, deviations, and CAPA management; familiarity with Quality Systems.
Experience presenting program metrics and status to senior leadership.
Experience with SIMCO or similar CMMS/asset management software.
Strong leadership and collaboration skills; successful delivery within a multicultural, matrixed environment.

Responsibilities

Ensure the right internal and external resources are in place to deliver metrology, calibration, and maintenance services that meet customer commitments and drive equipment reliability.
Troubleshoot equipment and process issues, resolve scheduling and technical conflicts, and escalate risks using established procedures to protect production schedules and compliance.
Provide expertise for analytical and manufacturing equipment; develop robust maintenance and calibration programs that improve uptime and data integrity.
Coordinate activities with Quality, Manufacturing, Laboratories, Facilities/Utilities, and EHS to land priorities on time and sustain customer satisfaction.
Prepare business cases, improvement plans, investigations, and metrics that inform metrology strategy, lifecycle decisions, and continuous improvement.
Maintain up-to-date knowledge of metrology standards and regulatory expectations (ICH, USP, EP, FDA) and share best practices across teams to raise the bar.
Ensure SOPs and standard processes (Good Documentation Practice, calibration/qualification, maintenance, change control) are followed and improved; escalate noncompliance to the right owners.
Define requirements, delivery models, and action plans for new equipment from initiation through IQ/OQ/PQ, aligning stakeholders and timelines to deliver right-first-time qualifications.
Stay current with tools, methods, and asset management software; advise on adoption and integration with site systems to enhance accuracy and efficiency.
Ensure all activities meet Health, Safety, and cGxP requirements; review vendor documentation for completeness and Good Documentation Practice.
Provide metrology support to Manufacturing and Laboratories, including analytical instrument management, stability chambers, balances, chart recorders, and related systems, to secure process control.
Lead Change Controls, deviations, and CAPAs for metrology and facilities-related systems; maintain the validated state of qualified systems through disciplined change management.
Obtain quotations, raise purchase requisitions, and manage service agreements for calibration, maintenance, and qualification services to ensure value and performance.
Oversee asset master data, labeling, and hierarchy in the CMMS/asset management system; support implementation, maintenance, testing, and reporting to ensure data integrity and traceability.
Maintain equipment regulatory compliance and audit readiness for internal and external inspections across maintenance, calibration, and instrument qualification programs.