Cleaning Validation Subject Matter 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

About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.

cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.

Position Summary

cGMP Consulting is seeking an experienced and driven individual to lead and manage cleaning validation activities, prepare and execute protocols, and act as SME regarding cleaning development and validation. This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment.

The ideal candidate will have a proven ability to lead cross-functional initiatives, navigate complex troubleshooting challenges, drive change management efforts, and ensure timely and thorough completion of protocols. This candidate has deep experience in current Good Manufacturing Practices (cGMP), along with a solid understanding of FDA regulations, and international compliance standards.

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

Requirements

• Minimum Bachelors’ degree in Engineering, Science, or a related field of study.


• 4+ years’ experience in a GMP manufacturing environment, including cleaning validation. Must be familiar with regulatory (FDA) requirements.


• Expertise in multiple areas: 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.

Compensation And Benefits

• Expected pay range per year: $120,000-$160,000 USD


• Expected benefits include: Medical, Dental, Vision, PTO, 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.