Cleaning Validation SME Position Available In Wake, North Carolina

Job Description:

12 months

Shift:

Primarily Day Shift; potential for Night Shiftwork in the future

Job Summary:

We are seeking an experiencedCleaning Validation Subject Matter Expert (SME) to lead and executecleaning validation activities in a dynamic biopharmaceuticalenvironment. This role focuses on Cleaning-In-Place (CIP)processes, cleaning validation execution, and large equipmentcleaning strategies, including bio-reactors. The ideal candidatewill bring expertise in cleaning validation, MACO (MaximumAllowable Carryover) assessments, and method validation, ensuringcompliance with regulatory requirements and company standards.

KeyResponsibilities:

Lead cleaning validation activities, includingCIP cycle development, execution, and optimization for largeequipment (e.g., bioreactors, tanks, and ancillary systems).Conduct cleaning validation studies, execute protocols (IOQ/PQ),and ensure thorough documentation in compliance with regulatoryrequirements (e.g., FDA, EMA). Perform MACO calculations andassessments to determine acceptable residue limits for equipmentcleaning. Collaborate with cross-functional teams to design andexecute cleaning validation strategies and methodologies. Developand execute cleaning validation protocols and reports, ensuringcompliance with cGMPs and ALCOA principles. Provide subject matterexpertise in cleaning validation execution and troubleshooting forcleaning processes. Lead method validation efforts related tocleaning validation (e.g., swab and rinse sampling). Ensurealignment with process and equipment design specifications forcleaning requirements. Provide technical training and guidance tooperators and validation personnel on cleaning validationprinciples and techniques. Support audits and inspections byproviding cleaning validation documentation and expertise. Mayparticipate in shift work as required to support cleaningvalidation activities during different phases of production.

Qualifications:

Bachelor’s degree in a relevant scientific orengineering discipline (e.g., Chemical Engineering, Biotechnology,Chemistry) or equivalent experience. 5 years of experience incleaning validation, with a strong focus on CIP processes and largeequipment. Proven expertise in MACO calculations, cleaningvalidation protocol execution, and method validation techniques.

Familiarity with biopharmaceutical manufacturing processes andregulatory standards (21 CFR Part 11, ICH Q7, etc.). Hands-onexperience with large-scale equipment, including bio-reactors,tanks, and associated cleaning systems. Strong problem-solvingskills and ability to troubleshoot cleaning-related issueseffectively. Excellent technical writing and documentation skills.

Flexibility to work day and night shifts as operational needsevolve.

Preferred Qualifications:

Experience in a large-scalebiopharmaceutical manufacturing environment.

MACO- MUST

KNEATexperience a plus Knowledge of automated cleaning systems and CIPequipment design. Familiarity with process validation andcross-contamination control strategies. Small Parts COP and CIPexecution experience