Quality Assurance Validation Specialist

1 week ago


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

Validation Engineer

Contract role focused on validation processes

Our organization is seeking a Validation Engineer to support our pharmaceutical manufacturing operations. This role involves providing essential technical assistance in the validation and requalification of equipment, systems, and processes.

Key Responsibilities:

• Plan and execute equipment requalification in accordance with established Standard Operating Procedures (SOPs). Collaborate with relevant departments to communicate testing schedules and assess results. Compile and distribute the final validation report for necessary approvals.

• Conduct validation studies across various domains including utilities, equipment, cleaning, processes, and computer systems. This includes preparing protocols, executing validation tasks, and drafting final reports, with presentations to regulatory bodies as required.

• Operate and program analytical instruments within the department, such as temperature and humidity data loggers, to qualify controlled environments like lyophilizers and sterilizers.

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

• Execute HEPA filter testing and critical area assessments following SOPs. Utilize testing equipment like smoke generators and photometers to capture and analyze results.

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

• Participate in investigations of deviations to identify root causes and establish corrective and preventive actions (CAPA).

• Support the continuous improvement of the ISO 50001 energy management system.

• Identify opportunities for energy savings and recommend strategies for more efficient operations.

• Monitor and analyze energy usage to optimize performance.

Qualifications:

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

• 3-5 years of relevant experience, including 1-3 years in a cGMP environment with a focus on sterilization.

• 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 to access controlled areas of the facility.

• Experience with analytical data logger programming and troubleshooting is preferred.

• Familiarity with Installation, Operational, and Performance Qualification protocols is advantageous.

• Understanding of statistical analysis tools and methodologies is a plus.

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

• Awareness of cGMP cleaning validation and process validation requirements is beneficial.

• Experience in cGMP CAPA, root cause analysis, and risk assessment methodologies is preferred.



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