About Us  Headquartered in Princeton, New Jersey, USA, with offices in United Kingdom, Australia, Canada, India, and Germany, we are a leading privately-owned global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use.  Highly regulated companies choose Xybion to help them become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Since our founding in 1977, we have supported through software, services, and consulting, 100% of the top 20 global life sciences companies.   Serving more than 300 customers in 25 countries, we have the global scale and expertise to bring our employees around the world together to drive innovation, manage complex business processes, improve program administration and client service delivery.  Validation Lead: (8 to 10+ years’ experience in Life science/ pharmaceutical industry) Xybion is seeking a Validation Lead for our client computer validation/ qualification projects Key Responsibilities + Prepare, review and/ or approval of qualification and/or validation documentation (VMPs, specifications, protocols, summary reports etc.) in relation to computer systems, instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation. + Generating, communicating, and updating Validation document tracker. + Manage the archiving and filing of validation documentation associated with the project + Leading the review and disposition of all attribute and variable data for the program against customer specification / drawing e.g. Analysing and reporting of key measures eg. Ppk's, Cpk's, FOT/FAT visual inspections. + Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner. + Lead data/presentations and attend review meetings with the customer. + Support internal and supplier audits. + Trending and tracking of Validation data to drive improvements e.g., Sampling data, project protocols and reports. + Played a key role in Validation and Compliance + Experienced in handling multiple projects, project scheduling, Risk Management and building mitigation strategies, quality control measures, Resource Management + Lead validation, compliance, and quality team. + Strong understanding and experience on 21 CFR Part 11 (Electronic Records; Electronic Signatures), GAMP, GxP + Audit preparedness (internal and external), addressing audit points and process improvements. + Extensive experience in pharmaceutical, biotechnology a must. Should demonstrate adequate experience in validating/ qualifying Software & integrated products used in Pharma industry like QMS, DMS, CTMS/ LIMS, PLC/SCADA, BMS, ERP etc. + Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities + Strong experience in developing software test methods for medical device products + Strong experience in SAP ERP implementation. + Experience in the execution of commissioning and qualification of process control systems + GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others + Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department. + Able to identify and respond to complex problems, interpret complex data and draw valid conclusions. + Demonstrated experience in management of complex tasks and projects. + Excellent Communication & Organization skills Education: Minimum of Bachelor’s degree in a life science or technology field (work experience will be considered in lieu of required degree). Compensation: We offer highly competitive compensation, including base salary, sales commission, performance-linked bonus, along with a comprehensive benefits package. We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/ Xybion is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, colour, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.   Powered by JazzHR