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Validation Engineer

  • Anywhere

Company :
Lubrizol Ltd

Location :
Bethlehem, Pennsylvania

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
Date: Nov 3, 2020 Location: Bethlehem, Pennsylvania, US, 18017 Company: Lubrizol Corporation Lubrizol, a Berkshire Hathaway company, is a technology-driven global company that combines complex, specialty chemicals to optimize the quality, performance and value of customers’ products while reducing their environmental impact. Lubrizol produces and supplies technologies to customers in the global transportation, industrial and consumer markets. These technologies include lubricant additives for engine oils, driveline and other transportation-related fluids, industrial lubricants, and additives for gasoline and diesel fuel. In addition, Lubrizol makes ingredients and additives for home care and personal care products and pharmaceuticals, and specialty materials, including plastics technology and performance coatings in the form of resins and additives. Purpose: The validation of equipment, systems and processes used for the manufacture of various pharmaceutical products in clinical and commercial manufacturing through planned and documented testing. Ensure client and business needs are met while providing highest quality of work. Functions: Prepare and execute installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and process qualification (PRQ) protocols for equipment, systems and processes. Prepare qualification summary reports (QSR) and validation summary reports (VSR). Prepare and/or review user requirements specifications and data sheets for the purchase of new equipment and systems. Prepare and execute design qualification (DQ) and traceability matrix (TM) documents. Review and comment on vendor supplied equipment documentation such as (FRS, DDS, GA drawings, P & ID, etc.). Prepare and execute Factory/Site Acceptance Tests (FAT or SAT) for equipment. Prepare and/or review Standard Operating Procedures for equipment and systems. Minimum Requirements: Education: Bachelor of Science in a related field or equivalent education/training/experience Experience: 5+ years related experience in the pharmaceutical industry with direct experience with equipment qualification and validation Special Knowledge/Training: Thorough knowledge and training in writing and execution of quality documentation such as IQ/OQ/PQ, SOP, etc. Thorough knowledge of cleaning and sterilization validations including CIP, SIP, autoclave, VHP, etc. Knowledge and familiarity of various process equipment used in the pharmaceutical industry such as autoclaves, fillers, lyophilizers, pumps, vessels, mixers, etc. Thorough knowledge of GLP/GMP requirements as they pertain to documentation, equipment, systems and processes used in GMP manufacturing operations. Thorough knowledge and ability to read and understand technical documentation such as mechanical drawings, P & I drawings, specifications, data sheets, etc. Knowledge and ability to use test instruments such as multimeters, tachometers, ammeters, pH meters, etc. used during the validation process. Basic knowledge of PLC software such as RSLogix desirable. Skills/Abilities: Strong technical and analytical skills Good mechanical aptitude with the ability and disassemble and assemble process equipment Excellent time management skills Good written communication skills Excellent knowledge and skills of MS Office applications, especially Word and Excel While headquartered in the United States, Lubrizol is truly a global specialty chemical company. We have a major presence in five global regions and do business in more than 100 countries. Our corporate culture ensures that Lubrizol is one company throughout the world, but you will find each region is a unique place to work, live and play. Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law. Nearest Major Market: Allentown Job Segment: Developer, Manufacturing Engineer, Engineer, Pharmaceutical, Testing, Technology, Engineering, Science