Validation Engineer

Contract, 3 months | Automated Systems, Inc. | United States

Posted On 08/14/2024

Job Information

Pharma/Biotech/Clinical Research

State/Province: Illinois

City: Melrose Park

Zip Code: 60161

Job Description

Validation Engineer

Contract position 3+ month contract - ONSITE

We currently have an opportunity for a Sr. 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 requalifications.

Responsibilities

1. Schedules and executes equipment requalifications 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.
2. 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.
3. Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers warehouses, sterilizers, incubators, etc.).
4. Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
5. 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.
6. Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
7. Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
8. Maintains and constant improvement of the ISO 50001 energy management system.
9. Identifies energy savings opportunities and makes recommendations to achieve more energy efficient operation.
10. Monitors and analyzes energy consumption.

Requirements

1. Bachelor's degree in Science or Engineering.
2. 3-5 years of related experience with 1-3 years in a cGMP facility with sterilization experience.
3. Knowledge of cGMPs, industry guidance, and aseptic techniques.
4. Ability to write reports and record data and a basic understanding of statistical analysis; generate reports, deviations or other technical documents.
5. Comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000).
6. Installation, Operational and Performance Qualification protocol generation and execution desired.
7. Understanding of statistical analysis tools and methods preferred.
8. Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques desired.
9. Knowledge of cGMP Cleaning Validation and cGMP Process and Product Validation requirements and techniques desired.
10. Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques desired.