Validation Engineer (CQV, Equipments)

Job Responsibilites:

While performing services as a contractor through our company, Beneficiary's job duties as
a Commissioning, Qualification, Validation Engineer providing CQV Support will include:

• Developing and executing Commissioning protocols and Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) protocols for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to single use mixers, controlled temperature units, laboratory equipment and aseptic filling line equipment in a newly constructed Bio-Pharmaceutical manufacturing suite.
• Perform Validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures)
• Determine impact on product quality by performing system level and component level assessments on manufacturing equipment.
• Support the Cycle Development tasks needed for autoclaves, parts washers, vaporized hydrogen peroxide sterilization, and clean in place skids.
• P&ID verification including redlining of drawings for 'as build'/turn over packages (TOP), Elastomer, MOC, Surface Finish, Weld procedure specification (WPS), Procedure Qualification Record (PQR), Welder performance Qualification (WPQ), Isometric Drawing, Weld log and weld inspection, Material Test Report (MTR), Slop Verification.
• Commission and qualify utilities such Clean Compressed Air, Nitrogen, Water For Injection, and Clean Steam.
• Performed pre and post calibration activities for Kaye Validator used for temperature mapping of Controlled temperature units (Freezers, refrigerators, and incubators).
• Min, Max, and Average temperatures recorded during temperature mapping, calculation of standard deviation and regression.
• Assist with the management of software and equipment and related data, in compliance with relevant company SOPs and CGMP regulatory guidelines.
• Involved in the development and updating of System Level Validation Plans (SLVPs).
• Reviewing the vendor Turn Over Packages (TOP), Site acceptance Test (SAT) Protocols provided by vendor, Equipment manuals, GA Drawing, and documentation in compliance with relevant company Specifications (User requirement specification - URS and Functional Requirement Specification - FRS).
• Facilitate formal, technical, and editorial reviews and submission of final draft for approval as per the quality process.
• Work in accordance with GDP regulations for recording, correcting, and managing data, documents, and records.
• Writing Exception Reports that includes Corrective and Preventive actions (CAPA) for the Non-Conformances/Deviations occurred, Evaluate and trouble- shooting of deviations.
• Maintain the document control department, hard copy files, electronic files in accordance with FDA regulations, particularly 21 CFR 210, 211 and regulations.

Required Skills:

• Minimum 8+ years of experience in a GMP CQV
• Excellent communication ability, leadership skills and proven team player at diverse levels.
• Proficient in project planning and timelines to deliver the with great outcomes.
• Needs to have hands on experience and in-depth technical understanding of process support equipment
• Waters Empower (HPLC), Kaye Validator, Kaye AWS, Data Loggers, Thermo Scientific Incubators, Autoclaves (Fedegari, Steris and Belimed Autoclaves), Groninger Fill Line Machines, Automated Inspection Machines, Packing and production equipment