Engineering Associate

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

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 Assessment’s.
• Coordinate with cross functionality teams to initiate and close Change Controls, CAPA’s 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.
• 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 $24.00/Hr. Max

USD $26.00/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

Job requires you to worker to reach or work above the shoulder

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.

• 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 Assessment’s.
• Coordinate with cross functionality teams to initiate and close Change Controls, CAPA’s 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
• 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.