Facilities and Production Maintenance Technician

AstraZeneca•Durham, NC

About The Position

The GMP Equipment Manufacturing Maintenance Engineer is responsible for the safe, reliable operation and maintenance of manufacturing and utility systems supporting pharmaceutical production environments—including oral solid dose (OSD) and inhaled product areas. This role ensures uptime of critical manufacturing equipment, accurate completion of work requests, and excellent service to production partners.

Requirements

Minimum of a 4-year bachelor’s degree in engineering (mechanical, electrical, chemical, industrial, or a closely related technical discipline)
Minimum of 0-5 years experience is required
Hands-on experience in GMP/pharmaceutical manufacturing maintenance, including experience in Quality Systems (CAPA, Deviations, SOP writing, Change Controls)
Proficiency in mechanical, electrical, and automation/controls maintenance for manufacturing equipment, including OSD and inhaled product systems (pMDI, spray drying, filling systems).
Ability to read schematics and equipment manuals; familiarity with BMS/PLC controls
Strong understanding of GMP, safe work practices, and thorough documentation
Skilled in CMMS work order systems and standard diagnostic tools
Demonstrated troubleshooting, problem-solving, communication abilities; able to work independently or in teams and adapt to changing priorities; strong customer service orientation
Willingness to be on-call after hours or weekends if required

Nice To Haves

HVAC/R license, Universal EPA 608, electrical or plumbing certifications, OSHA-10/30, or similar
Background in GMP/GxP or pharmaceutical/biotech production support; experience with critical/clean utilities (RO/DI, CDA, N2, vacuum) for manufacturing
Experience with BMS/EMS platforms and data trending; comprehensive understanding of SOPs and change control

Responsibilities

Manufacturing Equipment Maintenance: Perform maintenance, troubleshooting, and repairs on GMP manufacturing equipment for oral solid dose (granulators, blenders, tablet presses, coaters, packaging lines, BMS/PLC controls) and inhaled products, such as pMDI (pressurized Metered Dose Inhaler), spray drying systems, filling lines, and associated automation systems.
Critical Utilities Support: Maintain and support production-critical utility systems, including RO/purified water, compressed gases (N2, CDA), and vacuum as required for equipment operation and GMP production areas.
Troubleshooting and Rapid Response: Diagnose and resolve mechanical, electrical, and automation/control issues affecting OSD and inhaled product equipment to promptly restore safe and compliant operations per SOPs and GMP regulations.
Preventive Maintenance: Execute and document preventive maintenance (PM) activities for all assigned equipment and utilities. Ensure PMs are completed on schedule and equipment history files are maintained for audit readiness.
Automation and Controls: Configure, operate, and maintain BMS or equipment controllers (such as PLCs/RTUs/VFDs) for manufacturing systems supporting OSD and inhaled product equipment. Manage alarms, perform calibrations, implement logic changes, validate updates, and maintain documentation in accordance with change control procedures.
Quality & Compliance: Ensure compliance with all GMP, Quality System, and safety procedures—including CAPA, Deviations, SOP writing, Change Controls, SHE, LOTO, and safe work permitting. Support environmental and equipment monitoring programs as needed.
Work Order Execution: Complete production equipment maintenance requests and work orders accurately and promptly. Deliver high-quality support to QA and manufacturing teams.
Vendor Coordination: Coordinate vendor activities for preventive and corrective maintenance, technical service, or equipment upgrades; ensure adherence to internal safety and GMP protocols.
Documentation: Accurately record equipment maintenance, calibration, and repair activities according to audit and regulatory requirements.
Cybersecurity: Support IT and cybersecurity best practices for networked manufacturing equipment systems: manage account/access controls, apply approved firmware/patches, report vulnerabilities, and ensure secure management of equipment and controls.