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Quality Assurance Validation Specialist
2 months ago
Position: Validation Engineer
Contract Duration: 3+ months
Location: Onsite
We are seeking a skilled Validation Engineer to join our team at Automated Systems, Inc. This role involves providing essential technical support for the validation of equipment, systems, and processes within our pharmaceutical manufacturing environment.
Key Responsibilities:
- Plan and execute equipment requalification in accordance with established Standard Operating Procedures (SOPs). Ensure effective communication with relevant teams and analyze test outcomes. Compile and distribute the final validation report for approval.
- Conduct validation studies, including utility, equipment, cleaning, process, computer, and new product validations. Prepare protocols, manage scheduling, execute tests, and finalize reports. Present findings to regulatory bodies as required.
- Operate and program analytical instruments to facilitate controlled temperature and humidity chamber qualifications, including various types of equipment.
- Enhance and update validation programs to align with current cGMP standards and industry practices.
- Oversee HEPA Filter and Critical Area testing as per SOP guidelines. Utilize testing equipment such as smoke generators and photometers to assess and document results.
- Act as a representative for Technical Services in collaborative efforts to specify, install, validate, troubleshoot, and maintain systems and processes.
- Engage in deviation investigations to determine root causes and establish corrective and preventive actions.
- 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 data.
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 Microsoft Office Suite (Word, Excel, PowerPoint, Project, Access).
- Comprehensive knowledge of cGMPs and certification requirements for access to Controlled Areas.
- Experience with analytical datalogger programming and troubleshooting is preferred.
- Knowledge of Installation, Operational, and Performance Qualification protocols is advantageous.
- Understanding of statistical analysis tools and methodologies is a plus.
- Familiarity with cGMP room classifications and HEPA filter testing techniques is desirable.
- Experience in cGMP Cleaning Validation and Process/Product Validation is beneficial.
- Knowledge of cGMP Corrective and Preventive Actions, root-cause analysis, and risk assessment methodologies is preferred.
Automated Systems, Inc. is a dynamic consulting firm focused on delivering a diverse range of technical challenges. As we experience rapid growth, we are in search of talented professionals to join our team. We offer competitive compensation and comprehensive benefits. Automated Systems, Inc. is an equal opportunity employer.
