Quality Assurance Engineer
2 weeks ago
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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