Validation Engineer

Job Summary Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalifications. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (Grade D, C and up to B/ A). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required. Salary Range: $70,000-$90,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT. · Schedules and executes equipment commissioning, qualification, and requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Analyzes data, composes a final report and circulates for approval. · Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation. Participates in presentation of results to Regulatory Agency when necessary. · Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.). · Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards. · Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment. · Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA). REQUIREMENTS · BS/BA degree in science, engineering, manufacturing technology or closely related field or equivalent experience in a manufacturing facility · Minimum 1-3 years pharmaceutical manufacturing experience · Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices · Strong technical knowledge and experience with pharmaceutical process, sterilization, and cleaning validation as related to sterile products · Must be proactive, have experience with high performance teams, strong interpersonal and project management skills · Must be able to interact with varying levels within the company · Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results · Strong conflict resolution skills · Must be willing to travel both domestically and internationally · Must be able to work multiple shifts as needed to meet deadlines Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the companys global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using Fresenius-kaabi.com which of course includes an extra a in Kabi. Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your drivers license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.