Alexion Pharmaceuticals, Inc. · 2 months ago
GMP Equipment Manufacturing Maintenance Engineer
Durham, North Carolina, United States of America
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expAlexion Pharmaceuticals, Inc. is seeking a GMP Equipment Manufacturing Maintenance Engineer responsible for the safe and reliable operation and maintenance of manufacturing and utility systems in pharmaceutical production environments. The role involves maintaining critical manufacturing equipment, ensuring compliance with GMP regulations, and providing excellent service to production partners.
BiotechnologyHealth CareMedicalTherapeutics
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
Required
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
Preferred
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
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. 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
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
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