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AstraZeneca · 2 days ago

GMP Equipment Manufacturing Maintenance Engineer

Durham, NC

Full-time

Onsite

New Grad, Entry, Mid Level

0+ years exp

AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. They are seeking a GMP Equipment Manufacturing Maintenance Engineer responsible for the safe and reliable operation and maintenance of manufacturing systems in pharmaceutical production environments. The role involves performing maintenance on critical equipment, ensuring compliance with GMP regulations, and supporting production-critical utility systems.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

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

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

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

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

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

Complete production equipment maintenance requests and work orders accurately and promptly. Deliver high-quality support to QA and manufacturing teams

Coordinate vendor activities for preventive and corrective maintenance, technical service, or equipment upgrades; ensure adherence to internal safety and GMP protocols

Accurately record equipment maintenance, calibration, and repair activities according to audit and regulatory requirements

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

Qualification

GMP manufacturing maintenanceMechanical maintenanceElectrical maintenanceAutomation/controls maintenanceBMS/PLC controlsQuality Systems (CAPA)CMMS work order systemsTroubleshootingCustomer service orientationHVAC/R licenseUniversal EPA 608OSHA-10/30Problem-solvingCommunication

Required

Education: Minimum of a 4-year bachelor's degree in engineering (mechanical, electrical, chemical, industrial, or a closely related technical discipline)

Experience: 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)

Technical Skills: 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

Compliance and Safety: Strong understanding of GMP, safe work practices, and thorough documentation

Systems: Skilled in CMMS work order systems and standard diagnostic tools

Other Skills: Demonstrated troubleshooting, problem-solving, communication abilities; able to work independently or in teams and adapt to changing priorities; strong customer service orientation

Availability: Willingness to be on-call after hours or weekends if required

Preferred

Certifications: HVAC/R license, Universal EPA 608, electrical or plumbing certifications, OSHA-10/30, or similar

Industry Exposure: Background in GMP/GxP or pharmaceutical/biotech production support; experience with critical/clean utilities (RO/DI, CDA, N2, vacuum) for manufacturing

Systems: Experience with BMS/EMS platforms and data trending; comprehensive understanding of SOPs and change control

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)