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Quality Assurance Validation Specialist
2 months ago
Validation Engineer
Contract Opportunity
We are seeking a skilled Validation Engineer to support our operations in a pharmaceutical manufacturing environment. This role focuses on the technical aspects of equipment/system/process validation and requalification.
Key Responsibilities:
- Plan and conduct equipment requalification in accordance with established Standard Operating Procedures (SOPs). Collaborate with relevant teams to ensure comprehensive testing and evaluation of results. Prepare and distribute final reports for approval.
- Implement validation studies across various domains including utilities, equipment, cleaning, processes, and computer systems. Prepare protocols, execute studies, and compile final reports, presenting findings to regulatory bodies as required.
- Operate and program analytical instruments for controlled environment qualifications, including temperature and humidity chambers.
- Enhance and maintain validation programs to align with current cGMP standards and industry best practices.
- Conduct HEPA Filter and Critical Area testing per SOP, utilizing specialized test equipment to capture and analyze results.
- Act as a representative for Technical Services in multidisciplinary teams focused on the specification, installation, validation, troubleshooting, and maintenance of systems and equipment.
- Engage in deviation investigations 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 monitoring consumption.
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.
- Strong knowledge of cGMP regulations, industry guidelines, 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).
- In-depth understanding of cGMPs and the ability to work in controlled environments.
- Experience with analytical datalogger programming and troubleshooting is preferred.
- Familiarity with Installation, Operational, and Performance Qualification protocols is advantageous.
- Knowledge of statistical analysis tools and methodologies is a plus.
- Understanding of cGMP room classifications and testing techniques for HEPA filters and airflow patterns is desired.
- Experience in cGMP Cleaning Validation and Process/Product Validation techniques is beneficial.
- Knowledge of root-cause analysis, risk assessment, and corrective action processes is preferred.
