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Validation Manager

Company: Lubrizol Ltd
Location: Bethlehem
Posted on: February 15, 2020

Job Description:

Date: Feb 9, 2020 Location: Bethlehem, Pennsylvania, US, 18017 Company: Lubrizol Corporation Particle Sciences, A Lubrizol Company is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world's largest pharmaceutical and biotech companies to small VC backed -ups. As a member of the Particle Sciences, Inc. team, you will be working for a company that is engaged in important, exciting, and socially relevant projects. Particle Sciences is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth. To learn more about Particle Sciences, A Lubrizol Company, visit and The Validation Manager will be responsible for managing all aspects of validation within the facility. This will include the scheduling, writing and execution of validation activities for equipment, systems and processes used for the manufacture of various pharmaceutical products in clinical and commercial manufacturing. Ensure client and business needs are met while providing highest quality of work. Functions: Day to day management of internal and external resources, planning and assigning work for Validation Specialists and/or contingents in order to meet the goals and deadlines set forth. Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks. 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, review and execute Factory/Site Acceptance Tests (FAT or SAT) for equipment. Prepare, edit and/or review change controls, SOPs, specifications and other related documents. Train, mentor and advise less experienced validation team members. Minimum Requirements: Education: Bachelor's degree in Mechanical Engineering or related engineering degree or equivalent education/training/experience Experience: 7+ years related experience in the pharmaceutical industry with direct experience with equipment qualification and validation. 2+ years proven experience managing people and projects 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. Thorough knowledge and familiarity of typical process equipment used in the pharmaceutical industry. 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 of validation of 21CFR Part 11 compliant computerized systems and equipment. Knowledge and ability to use hand tools and test instruments such as Kaye Validator, multimeters, tachometers, ammeters, etc. used during the validation process. 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 Good team/people management skills Excellent knowledge and skills of MS Office applications, especially Word and Excel Particle Sciences' headquarters is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown, Bethlehem and Easton. The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action. Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play. This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife. From the yearly Musikfest festival, to skiing in the Poconos, to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley. 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. Do You Need Assistance? Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process. You can either call and ask for Talent Acquisition or send an to . Please note that this phone line and address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters. Nearest Major Market: Allentown Job Segment: Developer, Biotech, Engineer, Manager, Pharmaceutical, Technology, Science, Engineering, Management

Keywords: Lubrizol Ltd, Bethlehem , Validation Manager, Executive , Bethlehem, Pennsylvania

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