Senior Cleaning Validation Specialist Job

· Responsible for all respects of validation processes like- documenting commissioning activities, establishing the process, and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.

· Execute calibration, repair and design systems and complex machinery.

· Focusing on Equipment, process and cleaning validation.

· Prepare and maintain testing equipment.

· Operate thermal mapping equipment.

· Provide Validation Engineering and Technical Support for Process Equipment, Cleaning and Requalification Validation for units such as Autoclaves, Fermentor, Formulation tank, Buffer Tank and other Biotech Process Equipment in accordance with regulatory compliance.

· Plan, execute, and document cleaning validation activities to ensure effective removal of product residues, cleaning agents, and contaminants in compliance with cGMP and regulatory requirements.

· Perform and support swab and rinse sampling and analyze results to confirm equipment cleanliness meets regulatory and product-specific standards.

· Develop and validate CIP (Clean-in-Place) /SIP (Sterilize-in-Place) cycles, including parameters (time, temperature, flow rate, pressure, chemical concentration) and ensure they meet regulatory and product-specific standards.

· Analyzing test data to determine the causes of defects, failure, or flaws and facilitating corrective measures.

· Analyze results to confirm equipment cleanliness meets regulatory and product-specific standards.

· Authorize qualification protocols, field execution of approved protocols, authoring of final reports and participation in the resolution of protocol deviations and/or discrepancies.

· Keeping abreast of developments and innovation in process control engineering.

· Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, Impact Assessments, and other Quality Systems.

· Provide support for Cycle Development and Performance Qualification for the Dry Heat Sterilization, Moist Heat Sterilization, Cold Chain management, Container Closure Validation, Utilities Validation including incubators.

· Collaborate with cross-functional teams (QA, QC, Production, Engineering) to perform sampling, analyze results, manage deviations, and maintain audit-ready validation records.

· Write, execute, and review complex protocols and coordinate validation activities from other departments.

· Training staff on validation parameters, overseeing validation technicians, and documenting processes.

· Ensure to work on qualification of Utilities, Systems and Rooms.

· Verify installation and operation of Autoclaves, Ovens, Isolators, HVAC system and plant utility systems during commissioning projects.

· Generate and execute Qualification/Validation documents including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Summary Reports.

· Develop, coordinate, and monitor all aspects of the manufacturing process.

· Interface with Facilities and Manufacturing personnel along with equipment SME’s

· Write performance requirements for process development and engineering projects and validate the product and process.

· Investigate equipment failures and difficulties to diagnose faulty operation and recommend remedial actions during the process.

· Perform Thermal mapping validation for Autoclaves and Dry Heat Ovens.

· Utilize Kaye validator 2000 and Data Loggers for performing Steam-In-Place (SIP) Heat penetration studies, Experience with placing and removing Biological Indicators and Chemical Indicators.

Bachelor's Degree is required in Mechanical Engineering or Engineering Management.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave