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Senior Validation Specialist

2 months ago

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

Position Title: Validation Engineer

Employment Type: Contract position, 3+ month duration - ONSITE

Overview: We are seeking a skilled Validation Engineer to provide essential technical support at our pharmaceutical manufacturing facility. This role involves overseeing equipment/system/process validation and requalification activities.

Key Responsibilities:

  • Plan and conduct equipment requalifications in accordance with established Standard Operating Procedures (SOPs). Ensure effective communication with relevant departments and assess test outcomes. Compile and distribute the final validation report for approval.
  • Implement validation studies, including utility, equipment, cleaning, process, computer, and new product validations. Prepare protocols, manage schedules, execute tests, and prepare final reports. Present findings to regulatory bodies as required.
  • Operate and program analytical instruments within the department to qualify controlled temperature/humidity chambers, including various equipment such as lyophilizers and sterilizers.
  • Enhance and update validation programs to align with current cGMP standards and industry practices.
  • Conduct HEPA Filter and Critical Area (Class 100) testing as per SOP. Utilize testing equipment like smoke generators and photometers, and document and analyze results.
  • Represent Technical Services in collaborative teams tasked with specifying, installing, validating, troubleshooting, and maintaining systems, equipment, and processes.
  • Engage in deviation investigations to identify root causes and propose corrective and preventive actions (CA/PA).
  • Support the continuous improvement of the ISO 50001 energy management system.
  • Identify opportunities for energy savings and recommend strategies for enhanced operational efficiency.
  • Monitor and analyze energy consumption trends.

Qualifications:

  • Bachelor's degree in Science or Engineering.
  • 3-5 years of relevant experience, including 1-3 years in a cGMP environment with sterilization knowledge.
  • Familiarity with cGMPs, industry guidelines, and aseptic techniques.
  • Proficient in report writing and data recording, with a foundational understanding of statistical analysis.
  • Competent in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Access).
  • Thorough understanding of cGMPs and eligibility for certification to access Controlled Areas of the facility.
  • Experience in programming, operating, and troubleshooting analytical dataloggers is preferred.
  • Knowledge of Installation, Operational, and Performance Qualification protocol development and execution is desirable.
  • Familiarity with statistical analysis tools and methodologies is advantageous.
  • Understanding of cGMP room classifications, HEPA filter testing, and airflow pattern testing techniques is beneficial.
  • Experience with cGMP Cleaning Validation and cGMP Process and Product Validation requirements is a plus.
  • Knowledge of cGMP CA/PA, root-cause analysis, risk assessment, and investigation methodologies is preferred.