Validation Engineer

Validation Engineer is needed to perform the following duties: Write, execute, and review complex protocols and coordinate validation activities from other departments. Author and review various Validation Deliverables including Validation Plan, SOPs, IQ/OQ/PQ Protocols, and Final Reports. Performed IQ, OQ, PQ of integrated Vial Washing machine, Tunnel, Isolators, Vial Filling machine/LAF, Lyophilizer, vial sealing machine, Vial inspection machine, Steam Sterilizer and packing line equipment’s. Authored the protocols for Vial washing machine qualification to develop the cleaning cycles for different-different sizes of vials. Execution of temperature mapping of Lyophilizer, refrigerators and other CTU using Kaye Validator 2000, Kaye AVS and Kaye Val Probes. Leader in change control processes in validating the drug products. Authored, reviewed and execute the Traceability Matrix /IQ/OQ/PQ and final reports. Develop and review the User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS). Statistical analysis of product performance. Timely monitoring the product performance using control charts and Lean Six Sigma methods. Evaluated Criticality of the Equipment based on the equipment used and critical quality attributes for products. To ensure complaint handling and investigation with appropriate measures taken to prevent reoccurrence. Commissioning Standard Operating Procedures, and specifications for packaging equipment. Assure that validation activities are carried out within the regulatory requirements in terms of validation, operating procedures, and training to assigned personnel. Ensure that all Changes are monitored through Change Control system. #J-18808-Ljbffr ND Global Consulting Services, Inc