Quality Assurance Validation Specialist
2 weeks ago
Validation Engineer Position Overview
This role involves a contract engagement focused on providing critical technical support within a pharmaceutical manufacturing environment.
Key Responsibilities:
• Execute equipment requalification in accordance with established Standard Operating Procedures (SOPs). Collaborate with relevant departments to ensure thorough testing and evaluation of results. Prepare and disseminate final reports for necessary approvals.
• Conduct validation studies encompassing utility, equipment, cleaning, process, computer systems, and new product validations. Prepare protocols, manage scheduling, execute protocols, and compile final reports, presenting findings to regulatory bodies as required.
• Operate and program analytical instruments to facilitate controlled temperature and humidity chamber qualifications, ensuring compliance with industry standards.
• Enhance and maintain validation programs to align with current cGMP regulations and industry best practices.
• Perform HEPA Filter and Critical Area testing per SOPs, utilizing various testing equipment to capture and analyze results.
• Act as a representative of Technical Services in cross-functional teams dedicated to specifying, installing, validating, troubleshooting, and maintaining systems and equipment.
• Participate in deviation investigations to determine root causes and propose corrective and preventive actions.
• Support the continuous improvement of the ISO 50001 energy management system, identifying opportunities for energy savings and optimizing operational efficiency.
• Monitor and analyze energy consumption metrics to drive 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 with sterilization processes.
• Familiarity with cGMP guidelines, industry standards, and aseptic techniques.
• Proficient in report writing and data documentation, with a foundational understanding of statistical analysis.
• Competent in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Access).
• Comprehensive knowledge of cGMPs and certification requirements for entry into controlled environments.
• Experience with analytical datalogger programming and troubleshooting is preferred.
• Knowledge of protocol generation and execution for Installation, Operational, and Performance Qualification is advantageous.
• Understanding of statistical analysis tools and methodologies is preferred.
• Familiarity with cGMP room classifications, HEPA filter testing, and airflow pattern testing techniques is desirable.
• Experience in cGMP Cleaning Validation and Process/Product Validation methodologies is beneficial.
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