Job Title: Commissioning/Qualification Specialist

Location: Warren, NJ

Responsibilities:

• The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems.
• Primary responsibilities include qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system-related issues, and technical writing and execution.
• Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems

Experience/Minimum Requirements

• BS in Engineering required.
• Must be able to read and understand construction and mechanical drawings and P&IDs.
• Minimum of 3 years of experience in FDA-regulated industry.
• Minimum of 3 years of experience developing and execution facility and utility qualification.
• Strong background and experience in laboratory and manufacturing operations.
• Knowledge of cGMP in the pharmaceutical industry.
• Thorough knowledge and hands-on experience in commissioning and qualification of manufacturing facilities.

With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.