GMP Validation Engineer | IQ/OQ/PQ & Compliance

E Solutions, LLC; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

E Solutions, LLC seeks a Validation Engineer in Indianapolis, IN to manage commissioning and qualification activities for new equipment. Candidates require a Bachelor's degree in a relevant field and at least five years of experience in a regulated environment.

The role involves ensuring compliance with FDA standards, maintaining documentation, and collaborating with engineering and regulatory teams. Occasional travel to client sites is required.

Qualifications

• Minimum of five years of experience in commissioning, validation, or qualification within a regulated environment.
• Experience executing IQ, OQ, and PQ protocols.
• Ability to work independently and collaboratively in teams.

Responsibilities

• Plan and execute commissioning and qualification activities.
• Maintain documentation related to commissioning and qualification.
• Develop and maintain validation procedures aligned with regulatory requirements.
• Identify and resolve deviations during commissioning or qualification activities.

Skills

Strong understanding of GMP, GAMP, and FDA regulatory standards

Technical writing and documentation skills

Problem-solving and troubleshooting abilities

Proficiency in Microsoft Office applications

Education

Bachelor’s degree in Engineering, Science, Business, Management, or a related field

Tools

Microsoft Office

Job description

E Solutions, LLC seeks a Validation Engineer in Indianapolis, IN to manage commissioning and qualification activities for new equipment. Candidates require a Bachelor's degree in a relevant field and at least five years of experience in a regulated environment.

The role involves ensuring compliance with FDA standards, maintaining documentation, and collaborating with engineering and regulatory teams. Occasional travel to client sites is required.