Cleaning Validation Subject Matter Expert
cGMP Consulting specializes 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. Based in Lake Forest, IL, we primarily serve clients in Melrose Park, IL; North Chicago, IL; Waukegan, IL; and Pleasant Prairie, WI.
About the role
We are seeking an experienced and driven individual to lead and manage cleaning validation activities, prepare and execute protocols, and act as a subject-matter expert in 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.
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
- Apply knowledge of cleaning agents and establish 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 underdeveloped 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 Bachelor’s degree in Engineering, Science, or a related field of study
- 4+ years’ experience in a GMP manufacturing environment, including cleaning validation
- Familiarity 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
Pay
Expected pay range: $120,000–$160,000 USD per year
Benefits
- Medical, Dental, and Vision coverage
- Paid Time Off (PTO)
- 401K retirement plan