CIP Cleaning Lead

Location: Holly Springs, NC

Shift: Night Shift Our Client is seeking an experienced CIP Cleaning Lead to support night shift operations at a biopharmaceutical manufacturing facility in Holly Springs, NC. This role is responsible for leading Clean-in-Place (CIP) and Clean-Out-of-Place (COP) cleaning activities for process equipment, ensuring compliance with cGMP standards, and supervising a team of cleaning technicians to maintain a validated, audit-ready state across manufacturing suites.

Key Responsibilities: Lead and coordinate CIP/COP cleaning operations for bioreactors, tanks, piping, and process equipment during night shift production. Supervise, train, and schedule a team of CIP technicians, ensuring adequate coverage and adherence to cleaning protocols. Execute and verify CIP cycles per approved SOPs, batch records, and cleaning validation protocols. Monitor CIP skid performance, troubleshoot deviations, and escalate equipment issues to Engineering/Maintenance as needed. Ensure all cleaning activities comply with cGMP, FDA, and site quality requirements; maintain accurate documentation and batch record entries. Support cleaning validation activities, including sampling, swabbing, and coordination with QA/QC for verification testing. Identify and report deviations, non-conformances, and investigate root causes; support CAPA implementation. Maintain a clean, organized, and safe work environment in accordance with EHS and GMP standards. Serve as the point of contact for CIP-related questions during night shift and coordinate handoffs with day shift leadership. Participate in continuous improvement initiatives to optimize cleaning cycle times and reduce downtime.

Qualifications: High school diploma or equivalent required; Associate's or Bachelor's degree in a technical field preferred.10+ years of experience in CIP/COP operations within a cGMP-regulated pharmaceutical, biotech, or food/beverage manufacturing environment; prior lead or supervisory experience preferred. Working knowledge of CIP skid systems, cleaning validation principles, and cGMP documentation practices. Familiarity with SAP, MES, or similar batch record/documentation systems is a plus. Strong leadership, communication, and problem-solving skills; ability to direct a team independently on night shift. Ability to work in a gowned cleanroom environment and lift up to 50 lbs as needed. Willingness and availability to work night shift, including weekends/holidays as required by production schedule.