Facilities Engineering Associate I

About the role

Aurolife Pharma’s North Carolina operations (under Aurobindo Pharma USA) play a key role in the company’s U.S. specialty and complex generics strategy, with Durham serving as a formulation and device-focused R&D hub and Raleigh supporting commercial manufacturing. The NC sites primarily focus on respiratory and inhalation products such as metered-dose inhalers, dermatology products including prescription topical creams and ointments, and complex dosage forms like transdermal delivery systems, nasal sprays, and other high-barrier specialty products.

Responsibilities

• Perform routine operation, monitoring, and maintenance of facility utilities, including HVAC systems, purified water systems, compressed air systems, boilers, chillers, and electrical equipment.
• Execute and track preventive and corrective maintenance activities on manufacturing and facility equipment to ensure reliable and compliant operations.
• Troubleshoot mechanical, electrical, instrumentation, and facility-related issues and implement effective corrective actions.
• Support equipment qualification, commissioning, validation, calibration, and requalification activities in compliance with cGMP requirements.
• Schedule and coordinate external vendors for calibration, maintenance, and service activities while ensuring timely completion and minimal disruption to operations.
• Collaborate with Production, Quality Assurance, Validation, and Engineering teams to plan maintenance and calibration schedules and support manufacturing operations.
• Maintain accurate maintenance records, work orders, logbooks, asset information, and engineering documentation.
• Create, revise, and maintain Facility & Engineering department Standard Operating Procedures (SOPs), forms, and related documentation.
• Ensure compliance with cGMP, safety regulations, environmental standards, and pharmaceutical industry guidelines.
• Assist in facility improvement projects, equipment upgrades, energy-saving initiatives, and continuous improvement programs.
• Participate in inspections, audits, investigations, and regulatory assessments related to facility, utility, and equipment systems.
• Follow established SOPs and contribute to maintaining a safe, efficient, and compliant work environment.
• Utilize engineering and maintenance software systems such as AutoCAD, PMMS, CMMS, DMS, Nicelon, QAMS, BMS, EMS and ERP systems to support daily operations, documentation, maintenance planning, and project activities.
• Expected to come on weekends and after hours in case of emergencies at the facility.

Qualifications

• Basic knowledge of cGMP regulations, FDA requirements, and pharmaceutical manufacturing practices.
• Understanding of facility utility systems, including HVAC, purified water systems, compressed air systems, boilers, chillers, and electrical distribution systems.
• Familiarity with preventive maintenance, calibration, validation, and equipment qualification activities.
• Experience with maintenance management and documentation systems such as CMMS, PMMS, DMS, QAMS, ERP systems, or similar platforms is preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint); experience with AutoCAD is a plus.
• Strong troubleshooting, analytical, and problem-solving skills.
• Excellent organizational, communication, and interpersonal skills with the ability to work effectively in cross-functional teams.
• Ability to manage multiple priorities and coordinate activities with internal stakeholders and external vendors.
• Strong attention to detail and commitment to maintaining accurate documentation and regulatory compliance.
• Knowledge of safety regulations and best practices within manufacturing or pharmaceutical environments.
• Ability to work independently as well as collaboratively in a fast-paced environment.
• Willingness to support off-shift, weekend, or on-call activities as required to support facility operations.