Senior Cleaning Validation Engineer

cGMP Consulting•Madison, WI

10d•$140,000 - $200,000

About The Position

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.

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.

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.