Cleaning Validation Engineers

• 7+
• North Carolina

Job Description

• Strategic Leadership:
• Lead the development and execution of a cleaning validation (CV) program sub-team tailored to the facility’s specific needs, for example CIP Lead or Small Parts Lead.
• Provide strategic direction for cleaning validation activities, ensuring alignment with FDA, EMA, and other regulatory requirements.
• Act as a trusted advisor to client leadership, providing insights on risk mitigation, process improvement, and compliance strategies.
• Advanced Technical Expertise:
• Oversee the design, execution, and review of cleaning validation protocols for complex systems (bioreactors, centrifuges, UFDF skids, parts washers).
• Evaluate DeltaV recipes, trends, and associated SOPs for process improvements.
• Identify and resolve complex technical issues, leveraging data-driven approaches and best practices to optimize processes.
• Cross-Functional Collaboration:
• Partner with client stakeholders (QA, QC, Operations, Engineering) to integrate cleaning validation efforts across departments seamlessly.
• Coordinate with global sites to adapt and localize SOPs, methods, and strategies for the North Carolina facility.
• Team Development and Mentorship:
• Train and mentor contractor teams and manufacturing personnel on cleaning validation processes, ensuring knowledge transfer and long-term capability building.
• Develop and implement comprehensive training for cleaning and manufacturing execution teams.
• Documentation and Tracking:
• Oversee the creation, review, and approval of validation documentation, ensuring completeness, accuracy, and compliance.  Draft risk assessments and grouping strategies.
• Work with project managers to track progress, identify potential bottlenecks, and maintain visibility into CV activities.
• Ensure timely resolution of deviations, discrepancies, and non-conformances related to cleaning validation.

• Education: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• Experience:
• 7-10+ years of experience in cleaning validation within the pharmaceutical or biotechnology industry, with a focus on leadership and strategic execution.
• Proven expertise in Cleaning-in-Place (CIP) systems and parts washers, including troubleshooting and optimization.
• Experience in global regulatory environments, including FDA, EMA, and other health authorities.
• Technical Proficiency:
• Proficiency in Cleaning-in-Place (CIP) systems and parts washers.
• Familiarity with analytical and microbial methods for residue testing.
• Experience with validation documentation tools (e.g., Kneat, TrackWise, Veeva).
• Leadership Skills: Demonstrated ability to lead cross-functional teams, mentor junior staff, and communicate effectively with leadership.
• Problem-Solving Expertise: Strong analytical skills to identify root causes, develop solutions, and implement process improvements.