Senior Cleaning Validation Lead — GMP Expert

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 leader to head and manage cleaning validation activities, develop and execute protocols, and serve as a subject matter expert on cleaning development and validation. This senior role offers autonomy, leadership, and influence in a fast-paced GMP manufacturing environment.

The ideal candidate will drive cross-functional initiatives, troubleshoot complex issues, manage change, and ensure timely completion of protocols with deep cGMP experience and solid

Qualifications

• Minimum Bachelors’ degree in Engineering, Science, or a related field.
• 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 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 specification results 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

Process improvement

Aseptic filling qualification

Technical writing

Communication

Education

Bachelor’s degree in Engineering or Science

Job description

cGMP Consulting is seeking an experienced leader to head and manage cleaning validation activities, develop and execute protocols, and serve as a subject matter expert on cleaning development and validation. This senior role offers autonomy, leadership, and influence in a fast-paced GMP manufacturing environment.

The ideal candidate will drive cross-functional initiatives, troubleshoot complex issues, manage change, and ensure timely completion of protocols with deep cGMP experience and solid