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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

Type: Contract position - ONSITE

Overview: We are seeking a highly skilled Validation Engineer to support our operations in the pharmaceutical manufacturing sector. This role is crucial for ensuring compliance with industry standards through effective validation of equipment, systems, and processes.

Key Responsibilities:

  • Plan and execute equipment requalifications in accordance with established Standard Operating Procedures (SOPs). Collaborate with various functional teams to communicate testing schedules and assess results. Prepare and distribute final reports for approval.
  • Conduct validation studies, including utility, equipment, cleaning, process, computer, and new product validations. Prepare protocols, manage execution, and compile final reports. Present findings to regulatory agencies as required.
  • Operate and program analytical instruments for controlled environment qualifications, including temperature and humidity chambers.
  • Enhance and update validation programs to align with current cGMP regulations and industry best practices.
  • Perform HEPA Filter and Critical Area testing as per SOP. Utilize testing equipment such as smoke generators and photometers to gather and analyze data.
  • Act as a representative for Technical Services in cross-functional teams focused on specifying, installing, validating, troubleshooting, and maintaining systems and equipment.
  • Engage in deviation investigations to determine root causes and develop corrective and preventive actions.
  • Support the continuous improvement of the ISO 50001 energy management system by identifying energy-saving opportunities and monitoring energy consumption.

Qualifications:

  • Bachelor's degree in a relevant field such as Science or Engineering.
  • 3-5 years of experience in validation, 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 recording, with a basic understanding of statistical analysis.
  • Competent in using Microsoft Office Suite (Word, Excel, PowerPoint, Project, Access).
  • Thorough understanding of cGMP requirements and ability to obtain certification for access to controlled areas.
  • Experience with analytical datalogger programming and operation is preferred.
  • Familiarity with Installation, Operational, and Performance Qualification protocols is advantageous.
  • Knowledge of statistical analysis tools and methods is preferred.
  • Understanding of cGMP room classifications and HEPA filter testing techniques is desired.
  • Experience in cGMP Cleaning Validation and Process/Product Validation techniques is beneficial.
  • Familiarity with cGMP Corrective Action/Preventive Action (CA/PA) processes and root-cause analysis is a plus.