Senior GMP Validation & Qualification Lead

cGMP Consulting Inc.; Illinois; On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

401(k)

PTO

Job summary

cGMP Consulting Inc. is seeking an experienced individual to lead validation and qualification activities in a GMP-compliant environment. The role involves significant autonomy and leadership for complex projects, ensuring compliance with regulatory standards.

The ideal candidate will have at least 5 years of experience in a GMP setting, strong technical and organizational skills, and familiarity with FDA regulations. This position offers a competitive salary and benefits including medical, dental, and 401(k).

Qualifications

• Minimum of 5 years’ experience in a GMP manufacturing environment.
• Must be familiar with regulatory (FDA) requirements.
• Hands-on experience with temperature validation equipment (e.g., Temptales, Kaye, etc.).

Responsibilities

• Lead development and authorship of specifications and documentation for validation projects.
• Oversee engineering projects from concept through execution.
• Direct and coordinate equipment commissioning activities.

Skills

Cleaning validation

Qualification of aseptic filling equipment

Temperature validation equipment

Technical writing

Organizational skills

Communication skills

Education

Bachelor's degree in Engineering, Science, or related field

Job description

cGMP Consulting Inc. is seeking an experienced individual to lead validation and qualification activities in a GMP-compliant environment. The role involves significant autonomy and leadership for complex projects, ensuring compliance with regulatory standards.

The ideal candidate will have at least 5 years of experience in a GMP setting, strong technical and organizational skills, and familiarity with FDA regulations. This position offers a competitive salary and benefits including medical, dental, and 401(k).