Temporary - Computer System Validation Specialist
Walkersville, MD

Job Description

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description SummaryTo maintain the computer systems quality and validation for computerized systems Job Description To coordinate the validation of GMP relevant computer systems within the Walkersville site, in line with internal and external, global and local guidelines and regulations Ensure that adequate standards are maintained, communicated and effectively implemented for all systems and associated computer infrastructure Consult and advise computer systems projects on the correct application of internal and external regulations Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans. Ensure that the internal regulations are in line with up to date regulatory requirements. Decides the minimum level of qualification and validation necessary for local systems to ensure compliance with all relevant regulations and industry guidance documents, as well as internal local and global regulations Provides expert technical IT guidance to the Head of Quality for GMP decisions regarding the validation of computerized systems Ensure that the requirements for the validation of local computerized systems are clearly defined in policies, standards, VMPs, and standard operating procedures Ensure that the requirements for the validation of computerized systems are communicated effectively to engineering, controls, QC, IT, QA and other relevant personnel, including system owners, within the Lonza organization Coordinate the validation of computer systems ensuring that appropriate actions are carried out and recorded in accordance with approved documented procedures and in compliance with regulatory requirements and Corporate Quality Standards Ensure that the change management process for evaluating new or revised software is implemented and that the appropriate validation activities are identified and carried out Participate as the quality representative on steering committees for all CSV and core business process projects to ensure that the necessary validation activities are identified and carried out Actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements & corporate standards In conjunction with engineering, controls, IT and other departments, evaluate new applications in order to identify validation requirements Act on behalf of, or be a conduit to, the Head of Quality on CSV issues to ensure that GMP issues are identified and addressed Familiarity with cGMPs, GAMP, ICH Q7A and basic validation practices (IQ/OQ/PQ) Understanding of the following computer systems: Programmable Logic Controllers (PLCs), Distributed Control Systems (DCS), Supervisory Control and Data Systems (SCADA), and PC based computer systems hardware and software Responsibilities Quality Responsibility Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Safety Responsibility Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensures all team members comply with safety rules and regulations. Job Scope Works on complex problems where analysis of situations or data requires an in depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules, and performance requirements are met. EducationBachelors: Computer and Information Science (Required) Work Experience Certifications Skills Language(s) Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.