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Validation Engineer
2 months ago
Validation Engineer
3+ month contract role
Melrose Park, IL Onsite
We currently have an opportunity for a Validation Engineer in our client's Melrose Park Pharmaceutical Manufacturing facility who will provide technical support to operations with equipment/system/process initial validation and equipment/system/process requalification.
Job Role Responsibilities
Schedules and executes equipment requalification per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates for approval.
Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers warehouses, sterilizers, incubators, etc.).
Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
Schedules and executes HEPA Filter and Critical Area (Class 100) testing per SOP. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., ; records and evaluates results.
Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Maintains and constant improvement of the ISO 50001 energy management system.
Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.
Monitor and analyze energy consumption.
Education, Experience and Skill Requirements:
Bachelor's degree in Science or Engineering.
3-5 years of related experience with 1-3 years in a cGMP facility with sterilization experience.
Knowledge cGMPs, industry guidance, and aseptic techniques.
Ability to write reports and record data and a basic understanding of statistical analysis; generate of reports, deviations or other technical documents.
PC literate (MS Word, Excel, PowerPoint, Project, Access) competency.
Comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000).
Analytical datalogger programming, operating, troubleshooting, data-collecting desired.
Installation, Operational and Performance Qualification protocol generation and execution desired.
Understanding of statistical analysis tools and methods preferred.
Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques desired.
Knowledge of cGMP Cleaning Validation and cGMP Process and Product Validation requirements and techniques desired.
Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques desired.
