Cleaning Validation Subject Matter Expert

Job Title

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 essential functions include, but are not limited to the following:

• 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.

• 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.

• Expected pay range per year: $120,000-$160,000 USD
• Expected benefits include:
  Medical, Dental, Vision, PTO, 401K

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.