CQV Engineer Job

CQV Engineer is needed to perform the following duties:

· Responsible for all aspects 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.

· Supporting in developing Validation Master Plan for: Execution of GMP Lab systems/Instrument/Equipment of Bio-pharmaceutical Product Development and Supply (BPDS) for, Cell Banking Manufacturing and Testing (CBMT).

· Development/Execution qualification (Commissioning/IOQ/IQ/OQ/PQ), Standard operating procedures (SOP), and specifications for Lab systems/Instrument/Equipment.

· Performed temperature mapping using the KAYE (2000) and Data loggers.

· And Validate control temperature units like controlled freezers, refrigerator, Autoclaves, Serialization equipment – vial filling machine.

· Analyze and Interpret Validation test data to determine whether systems of process have met validation criteria or to identify root cause of deviations

· Analyzed equipment’s: Autoclaves, Laboratory Freezers, Liquid Nitrogen Freezers, FT-IR (Software Upgrade), Metrohm Titrando, Aligent Open Lab CDS (Software Upgrade), Spectrophotometer, Laminar Flow Hood, Viscometers, Centrifuges, Microplate Readers and Instron (Software Upgrade). Execute Authors equipment, facility, utility and computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.

· Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and Test Standards .Involve in implementation of Implement/Validate automated visual inspection systems and all related validation documentation, engineering, regulatory and customer audits, and investigations with Business and Technical folks in finding a rationale for unresolved defects. Proficient in process improvement and documentation, leading, executing, and troubleshooting qualification activities for facility, utility and optimization of the biological and chemical process.

· Documentation include, but not limited to: Life cycle documents created and manage

· Risk Assessments, Validation Plans, Design Specifications, User Requirements, Function-

· al Requirements, IOQ, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, Summary Reports, change control, CAPA, Exceptional condition and risk assessments.

· Development including Create, review and modify of Standard operating procedures (SOPs), Maintenance Calibration Procedures, and other Instrument/ equipment support documentation.

· Developing and executing validation protocols maintaining Data integrity and ALCOA principles are essential to for a complaint paper and/or electronic data management life cycle system, complying
with GDPs, complying with GMPs, and driving data integrity initiatives.

· Original data is the paper or electronic medium in which the data point is initially recorded including protocol, database, or software application. Understanding where the original data is generated to ensure content and meaning are preserved.

Bachelor's Degree is required in Pharmacy or Pharmaceuticals Engineering or Pharmaceutical Science or Chemistry

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