The Cleaning Validation Specialist will join a leading global pharmaceutical company that is rapidly expanding its international presence, with plans to double in both size and production in the coming years. This role is part of a high-impact project focused on reducing batch changeover time and increasing operational efficiency. The Cleaning Validation Specialist will be responsible for executing cleaning validation activities, supporting CQV efforts, and collaborating with cross-functional teams to optimize manufacturing processes and ensure compliance with regulatory standards.

QUALIFICATIONS OF THE CLEANING VALIDATION SPECIALIST:

• Bachelor’s Degree in Engineering, Life Sciences, or a related technical field.
• Minimum 1 year of cleaning validation experience in a regulated manufacturing environment.
• CQV experience and familiarity with manufacturing floor operations highly preferred.
• Knowledge of cGMP documentation and regulatory standards.
• Strong soft skills: hunger, motivation, and ability to thrive in a fast-paced, execution-heavy environment.
• Experience with validation tools such as Kneat and Ellab.
• Strong analytical, problem-solving, and organizational skills.

• Cleaning Validation & Compliance Oversight:
• Execute cleaning and sterility validation (CVSV) studies, including swabbing, sample collection, and lab submissions.
• Enter sample data into validation software and develop validation reports.
• Ensure validation protocol data meets documented acceptance criteria and regulatory standards.
• CQV & Validation Process Management:
• Support commissioning, qualification, and verification (CQV) of tanks, piping systems, automated equipment, and other facility upgrades.
• Collaborate on IQ, OQ, and PQ protocols using Kneat software.
• Assist in filter integrity testing, temperature mapping (Ellab), and equipment qualification.
• Own and manage change controls, ensuring timely implementation and stakeholder communication.
• Lead deviation investigations and develop corrective action plans.
• Continuous Improvement & Operational Efficiency:
• Participate in workplace optimization and continuous improvement initiatives.
• Lead owner project management efforts including capital investment requests, scheduling, and team coordination.
• Uphold all safety and environmental standards in daily operations.