Engineering Associate
Aurobindo Pharma USA, Inc.
Summary
The Engineering Associate supports engineering, maintenance, quality, and project activities to ensure equipment, utilities, and processes comply with regulatory, quality, and operational requirements. This role is responsible for engineering documentation, qualification and validation activities, quality system management, continuous improvement initiatives, and cross-functional coordination to support efficient and compliant manufacturing operations.
Job description
Job Overview
The Engineering Associate supports engineering, maintenance, quality, and project activities to ensure equipment, utilities, and processes comply with regulatory, quality, and operational requirements. This role is responsible for engineering documentation, qualification and validation activities, quality system management, continuous improvement initiatives, and cross-functional coordination to support efficient and compliant manufacturing operations.
Responsibilities
- Preparation, Review and Approval of Engineering Drawings.
- Handling of quality management software.
- Planning and execution of equipment and Utility IQ/OQ qualifications.
- Planning and Preparation of Engineering Standard Operating Procedures, Risk Assessments.
- Coordinate with cross-functional teams to initiate and close Change Controls, CAPAs and deviations.
- Assist maintenance team in implementation of new tools, systems, and technologies to drive operational efficiency.
- Assist the engineering manager in preparing request for proposals for new equipment and projects.
- Assist the maintenance team to deploy software tools and techniques to enhance compliance.
- Assist the projects team in preparing cost estimates.
- Perform other duties as assigned.
- Follow the laid down Quality Culture Principles and Behaviors.
Qualifications - Skills & Requirements
- Master's degree in Engineering or a related technical discipline.
- Knowledge of GMP-regulated environments, qualification/validation practices, and quality systems is preferred.
- Familiarity with engineering documentation, maintenance systems, and quality management software.
- Strong analytical, organizational, and problem-solving skills.
- Effective communication and collaboration skills with cross-functional teams.
- Proficiency in Microsoft Office applications and engineering-related software tools.
Education & Experience
- Bachelor's/Master's Degree in Engineering.
- 0-2 years of experience in cGMP related Engineering activities.
Requirements
- Master's degree in Engineering or a related technical discipline
- Bachelor's/Master's Degree in Engineering
- 0-2 years of experience in cGMP related Engineering activities
- Knowledge of GMP-regulated environments, qualification/validation practices, and quality systems is preferred
- Familiarity with engineering documentation, maintenance systems, and quality management software
- Strong analytical, organizational, and problem-solving skills
- Effective communication and collaboration skills with cross-functional teams
- Proficiency in Microsoft Office applications and engineering-related software tools
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- FSA & HSA
- 401(k) Matching
- Employee Assistance Program
- Critical Illness & Accident Insurance
- Legal & Identity Theft Insurance
- Paid Time Off
Company overview
Aurobindo Pharma USA, Inc. (APUSA) is the U.S. sales and marketing arm of Aurobindo Pharma Limited, an Indian multinational pharmaceutical manufacturing company. Incorporated in 2004 and headquartered in East Windsor, New Jersey, APUSA is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients across the United States. The company has expanded its portfolio to include more than 150 product families representing a wide range of therapeutic categories, including antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics. APUSA leverages vertical integration and efficient controlled processes to provide superior customer service in the distribution of generic pharmaceuticals. The company has been recognized as one of the fastest-growing pharmaceutical companies and ranks among the top 10 pharmaceutical companies in terms of total prescriptions dispensed in the U.S. market. APUSA operates through several subsidiaries including Aurolife Pharma LLC, AuroHealth LLC, Acrotech Biopharma Inc., and others, extending its range of products and services across various pharmaceutical segments.