GMP Equipment Manufacturing Maintenance Engineer
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Job Location:
Durham, NC - USA
Monthly Salary:
USD 2025 - 2025
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Role Summary:
The GMP Equipment Manufacturing Maintenance Engineer is responsible for the safe reliable operation and maintenance of manufacturing and utility systems supporting pharmaceutical production environmentsincluding 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.
Key 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 proceduresincluding 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.
ESSENTIAL REQUIREMENTS
- Education: Minimum of a 4-year bachelors 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 EXPERIENCE
- 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
Date Posted
19-Dec-2025Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
