CIP Cleaning Lead

CORE, a Unicon Company; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

CORE, a Unicon Company, seeks an experienced CIP Cleaning Lead to support night shift operations at a biopharmaceutical facility in Holly Springs, NC. You will lead CIP/COP activities for process equipment, ensure cGMP compliance, and supervise a team of cleaning technicians.

Responsibilities include executing CIP cycles, monitoring skid performance, coordinating with QA/QC, and driving continuous improvement to reduce cleaning cycle times and downtime.

Qualifications

• 10+ years CIP/COP operations in cGMP environments.
• Strong leadership, communication and problem-solving skills.
• Experience working night shift and managing a team.

Responsibilities

• Lead and coordinate CIP/COP cleaning ops for bioreactors, tanks and piping on night shift.
• Supervise, train and schedule CIP technicians with proper coverage.
• Execute and verify CIP cycles per SOPs and validation protocols.
• Monitor CIP skid performance, troubleshoot deviations and escalate as needed.
• Ensure compliance with cGMP/FDA; maintain accurate batch records.
• Support cleaning validation activities including sampling and QA/QC coordination.
• Identify deviations, root causes and support CAPA implementation.
• Maintain a clean, organized and safe work environment per EHS/GMP.
• Serve as point of contact for CIP queries during night shift and coordinate handoffs.
• Participate in continuous improvement to reduce cycle times and downtime.

Skills

Leadership

Team supervision

Communication

Problem-solving

Night shift flexibility

Education

High school diploma

Associates degree

Bachelor's degree

Tools

SAP

MES

Job description

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.