CIP Cleaning Lead

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.