The Cleaning Validation Specialist for Operations is responsible for ensuring the effective and compliant cleaning processes within manufacturing and operational environments in accordance with regulatory standards and company policies. This role involves the development, implementation, validation, and ongoing monitoring of cleaning procedures to ensure product integrity, safety, and regulatory compliance.
Hands-on experience developing, executing, and reporting cleaning validation protocols (IQ/OQ/PQ) for manufacturing equipment and facilities.
Demonstrated ability to define acceptance criteria such as Maximum Allowable Carryover (MACO) and residue limits.
Experience selecting and validating cleaning agents, methods (CIP/SIP or manual cleaning), and residue testing techniques (e.g., HPLC, TOC, conductivity).
Expertise in performing risk-based assessments of cleaning processes to ensure compliance and minimize contamination risks.
Experience investigating cleaning failures or deviations, conducting root cause analyses, and implementing corrective and preventive actions (CAPA).
Familiarity with creating and managing change control processes for updated cleaning procedures.
Strong experience with cleaning validation for a variety of manufacturing equipment, including bioreactors, filtration systems, filling lines, and other process equipment used in pharmaceutical or biotech production.
Proficiency in residue analysis techniques such as swab and rinse sampling, TOC, and UV/Vis spectroscopy.
Proven track record of working with operations, quality assurance, and R&D teams to optimize and validate cleaning processes.