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Sr. Validation Engineer

Company: Xellia Pharmaceuticals USA, LLC
Location: Cleveland
Posted on: January 15, 2021

Job Description:

Would you like to join an award winning organization that is dedicated to saving lives?In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.Is that you? If so, we want to learn more about you!Our Bedford, OH facility is seeking a Validation Engineer who is responsible for demonstrating hands-on experience in developing and executing specifications, operating procedures, commissioning/qualification/validation protocols and reports to maintain "Systems" in validated state. Provide expertise for projects involving sterile operation and process packaging equipment as well as facility, utilities and computerized systems (CSV) validation program at Xellia, CLE.Key Responsibilities* Demonstrate skills set, knowledge and apply ASTM E2500 principles, and good engineering practices to the Site Validation Lifecycle concept.* Author, review, and execute commissioning, qualification (C&Q) and validation documentation.* Maintain Equipment/Facility/Utility (EFU) and computer validation program in accordance with Validation Master Plans and corresponding SOPs.* Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports; Risk Assessment; Tracebility Matrix, etc.) are compliant with the current regulations, current industry practices, and internal policies and procedures.* Execute and/or provide support with C&Q and validation activities of cross functional teams including MS&T, Engineering, Operations (sterile/non-sterile), and Quality as applicable.* Author of valid systems' inventory to maintain periodic review scheduling and revalidation program.* Apply a science and risk-based approach for "Systems" qualification activities to assess the need and/or extent of required validation efforts.* Generate and resolve qualification / validation protocol discrepancies/deviations and/or other impact investigation incidents.* Manage relationship with internal client group of operations, ensuring Xellia CLE manufacturing & packaging equipment and its processes are validated and in compliance for manufacturing.* Can be responsible to define C&Q, Validation requirements for technical transfer and/or new product/process introduction.Experience and Skills* Bachelor's degree in Engineering, Life Sciences, or related discipline (Chemical Engineering, Chemistry, Biology, Electrical, Mechanical, etc.).* A minimum of seven (7) years of hands-on, direct validation experience in pharmaceutical / biotech industries.* Champion to adopt / apply principles of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Systems and Equipment).* Recent and relevant to Sterilization Qualification, VHP Decontamination processes experiences, including EFU, packaging equipment and CSV validation.* Knowledge in writing, reviewing and executing C&Q, validation protocols and technical reports (including user/functional/design specifications).* Experience in change control process.* Working knowledge of applied risk assessment tools.* Ability to work independently and in a team environment to meet defined and assigned objectives based on established timelines and project scope.* Understand potential risk areas / shortfalls to deliver validations right first time.Preferred* Expertise with Isolator technology and sterile operations.* Demonstrate ability to read, comprehend and interpret equipment manuals, P&ID's, mechanical and electrical drawings and PLC logic.* Demonstrate skills in troubleshooting critical process or equipment issues.* Proven mechanical aptitude preferred: * Technology transfer / New Product/Process Introduction* Process development / Process improvements (Design Of Experiments, DOE).* Knowledge in serialization / aggregation process and packaging validationWe offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.Read more about Xellia Pharmaceuticals hereSDL2017

Keywords: Xellia Pharmaceuticals USA, LLC, Cleveland , Sr. Validation Engineer, Other , Cleveland, Ohio

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