Quality Assurance Engineer

2 weeks ago


Melrose Park, Illinois, United States Automated Systems, Inc. Full time

Validation Engineer Opportunity

This role is a contract position focused on supporting validation processes within a pharmaceutical manufacturing environment.

Key Responsibilities:


• Plan and execute equipment requalification in accordance with established Standard Operating Procedures (SOPs). Ensure effective communication with relevant departments and analyze testing outcomes. Prepare and distribute final reports for approval.


• Conduct validation studies encompassing utilities, equipment, cleaning, processes, computer systems, and new product introductions. Responsible for protocol development, execution, and final report generation, including presentations to regulatory bodies when required.


• Operate and program analytical instruments for the qualification of controlled environments, such as temperature and humidity chambers.


• Enhance and maintain validation programs to align with current Good Manufacturing Practices (cGMPs) and industry standards.


• Execute HEPA filter and critical area testing per SOPs, utilizing various testing equipment and documenting results meticulously.


• Act as a representative for Technical Services in cross-functional teams tasked with specifying, installing, validating, troubleshooting, and maintaining systems and equipment.


• Participate in investigations of deviations to identify root causes and propose corrective and preventive actions.


• Oversee the continuous improvement of the ISO 50001 energy management system, identifying opportunities for energy savings and enhancing operational efficiency.


• Monitor and analyze energy consumption patterns to support sustainability initiatives.

Qualifications:


• Bachelor’s degree in a relevant scientific or engineering discipline.


• 3-5 years of experience in a related field, with a minimum of 1-3 years in a cGMP environment, particularly in sterilization processes.


• Familiarity with cGMP regulations, industry standards, and aseptic techniques.


• Proficient in report writing and data documentation, with a foundational understanding of statistical analysis.


• Competent in using Microsoft Office Suite (Word, Excel, PowerPoint, Project, Access).


• Comprehensive knowledge of cGMPs and certification requirements for accessing controlled areas.


• Experience with analytical datalogger programming and troubleshooting is preferred.


• Skills in generating and executing Installation, Operational, and Performance Qualification protocols are desirable.


• Understanding of statistical analysis tools and methodologies is an advantage.


• Knowledge of cGMP room classifications, HEPA filter testing, and airflow pattern evaluation techniques is beneficial.


• Familiarity with cGMP cleaning validation and process validation techniques is preferred.


• Experience in conducting root-cause analysis and risk assessment in a cGMP context is a plus.



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