Senior Cleaning Validation SME - GMP & Compliance Lead

Cgmp-Consulting; 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 is seeking an experienced senior professional to lead and manage cleaning validation activities, prepare and execute protocols, and serve as SME on cleaning development and validation.

You will drive cross-functional initiatives in a fast-paced, GMP-compliant manufacturing environment, with emphasis on FDA regulations and international compliance standards. This role offers autonomy, leadership opportunities, and a direct impact on product quality and regulatory readiness.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 4+ years GMP manufacturing experience including cleaning validation.
• Expertise in cleaning validation, continuous process improvement, or qualification of aseptic equipment.
• Strong analytical thinking and technical writing.
• Excellent organizational and communication skills.

Responsibilities

• Design and develop cleaning procedures for new products 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 establishment of 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 and conduct troubleshooting or root cause analysis of cleaning related incidents, deviations and cleaning out of specificationresults for non validated or under developed cleaning procedures.
• Lead enhancement of cleaning practices and review and approve work instructions.
• Support the periodic review of cleaning validation studies.
• Perform successful resolution of incidents and deviations related to cleaning activities.
• Issue change controls required for implementation of cleaning procedure changes.

Skills

GMP manufacturing

Cleaning validation

Continuous process improvement

Technical writing

Communication skills

Education

Bachelor's degree in Engineering/Science or related field

Job description

cGMP Consulting is seeking an experienced senior professional to lead and manage cleaning validation activities, prepare and execute protocols, and serve as SME on cleaning development and validation.

You will drive cross-functional initiatives in a fast-paced, GMP-compliant manufacturing environment, with emphasis on FDA regulations and international compliance standards. This role offers autonomy, leadership opportunities, and a direct impact on product quality and regulatory readiness.