Facilities Engineering Associate I

Division Overview

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, which are considered specialty drugs due to their complex drug-device integration, along with dermatology products including prescription topical creams and ointments that require sophisticated formulation and bioequivalence approaches. In addition, the Durham facility supports development of transdermal delivery systems, nasal sprays, and other complex dosage forms, positioning the NC footprint as a center for high-barrier specialty products rather than conventional solid oral generics.

Job Overview

We are seeking a motivated Facility & Engineering Associate-I to support the operation, maintenance, and continuous improvement of facility systems and manufacturing equipment within a pharmaceutical production environment. The successful candidate will assist in maintaining utilities such as HVAC, water systems, compressed air systems, and cleanroom facilities while ensuring compliance with cGMP, safety, and regulatory requirements. Responsibilities include performing and tracking preventive maintenance activities, troubleshooting equipment issues, supporting equipment qualification, validation, and calibration activities, maintaining technical documentation, and collaborating with Production, Quality, Validation, and Engineering teams. This role is a hands on role and will also involve scheduling and coordinating external vendors for calibration, maintenance, and service activities, as well as working closely with cross-functional teams to plan and communicate schedules to minimize operational disruptions. This position is ideal for candidates with a degree in Mechanical, Electrical, or a related Engineering discipline who are eager to build a career in pharmaceutical manufacturing and facility engineering.

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 - Skills & Requirements

• 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.

Education & Experience

• Bachelor's Degree in Mechanical Engineering/Facilities or related field of study or equivelant
• 2-4 years of experience in facility engineering, maintenance, utilities, manufacturing, or a regulated pharmaceutical/biotechnology environment preferred

• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through CIGNA
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability
• Long-Term Disability (LTD), State (short term) disability - where applicable
• FSA (Flexible Spending Accounts) - Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off - Paid vacation, PTO, Holiday

Notice to Recruitment Agencies:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.

Compensation
Min

USD $23.00/Hr.
Max

USD $30.00/Hr.
Physical Requirements

FIELD - While performing the duties of this job the employee is required to: • Work in a temperature controlled office environment or travel via vehicle or commercial transportation • While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment • Position requires some degree of travel for business purposes • Employee may use computer, phone, copier and other office equipment in the course of a day • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements

Walking 5-8 Hours


Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.