Cleaning Validation Lead — GMP Compliance Expert

cGMP Consulting Inc.; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting Inc. seeks an experienced leader to head cleaning validation efforts in a GMP manufacturing setting, ensuring robust protocols and cross-functional collaboration.

The role offers significant autonomy and the chance to influence development and manufacturing practices under FDA and international standards. The ideal candidate brings deep cGMP experience, strong technical writing skills, and a proven ability to drive timely protocol execution and continuous improvement across

Qualifications

• Bachelor's degree in Engineering, Science, or related field required.
• 4+ years’ experience in a GMP manufacturing environment, including cleaning validation.
• Expertise in cleaning validation, continuous process improvement, and/or qualification of aseptic filling or formulation equipment/processes.
• Advanced critical thinking and technical writing skills.
• Strong organizational, communication, and interpersonal skills.

Responsibilities

• Design and develop cleaning procedures for new product and manufacturing equipment.
• Provide technical support to cleaning activities associated with the manufacturing process.
• Lead the cleaning validation program and activities.
• Knowledge of cleaning agents and sound cleaning practices within new or refurbished manufacturing rooms and sampling suite areas.
• Design and support implementation of cleaning strategies for product transfer projects and product development projects.
• Investigate root cause analyses of cleaning incidents, deviations and results.
• Lead enhancement of cleaning practices and approve work instructions.
• Support periodic review of cleaning validation studies.
• Resolve incidents and deviations related to cleaning activities.
• Issue change controls for cleaning procedure changes.

Skills

Leadership

Project management

GMP knowledge

Technical writing

Cross-functional

Education

Bachelor's degree in Engineering/Science

Job description

cGMP Consulting Inc. seeks an experienced leader to head cleaning validation efforts in a GMP manufacturing setting, ensuring robust protocols and cross-functional collaboration.

The role offers significant autonomy and the chance to influence development and manufacturing practices under FDA and international standards. The ideal candidate brings deep cGMP experience, strong technical writing skills, and a proven ability to drive timely protocol execution and continuous improvement across