GMP Validation Engineer II — Lead Projects & Compliance

cGMP Consulting Inc.; Illinois; On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting Inc. in Illinois is seeking a motivated individual for a mid-level role to lead projects in a GMP-compliant environment. This position requires a Bachelor's degree and 2-5 years of GMP manufacturing experience.

Key responsibilities include managing engineering projects and conducting validation studies while ensuring compliance with FDA regulations. Expected annual compensation ranges between $75,000 and $95,000, along with a comprehensive benefits package.

Qualifications

• 2-5 years’ experience in a GMP manufacturing environment.
• Familiar with regulatory (FDA) requirements.
• Hands-on experience with temperature validation equipment.

Responsibilities

• Author specifications and documentation for new processes.
• Manage engineering projects involving facility modifications.
• Lead equipment commissioning testing and validation studies.
• Assist in project forecasting and requirement planning.

Skills

Cross-functional collaboration

Troubleshooting

Change management

Technical writing

Organizational skills

Communication skills

Interpersonal skills

Education

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

Tools

Temperature validation equipment (e.g., Temptales, Kaye)

Word

Excel

Document Management Systems

Job description

cGMP Consulting Inc. in Illinois is seeking a motivated individual for a mid-level role to lead projects in a GMP-compliant environment. This position requires a Bachelor's degree and 2-5 years of GMP manufacturing experience.

Key responsibilities include managing engineering projects and conducting validation studies while ensuring compliance with FDA regulations. Expected annual compensation ranges between $75,000 and $95,000, along with a comprehensive benefits package.