Engineer 2 - Computer System Validation Our Offering Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Our Company About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Performance People Planet Community Global Quality Responsible Sourcing Careers Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Contact Our Offering Corporate Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Back Our Company Corporate About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Performance People Planet Community Global Quality Responsible Sourcing Back Careers Corporate Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Back Contact Corporate Back Engineer 2 - Computer System Validation Singapore, Tuas Singapore Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Did you know that we are the 1st biologics contract manufacturer in Singapore ? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network. The CSV Engineer will provide day-to-day Validation activities support in accordance with approved SOPs / Policies for a GMP Biotech manufacturing facility. The role supports Validation activities related to computerized system and is responsible to ensuring their integrity, compliance and efficiency from a Computerized System Validation (CSV) perspective. Key responsibilities: Support day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies. Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure. Participate in system design review to ensure compliance to user requirements, good engineering practice, validation requirements and regulatory standards. Review and approve of Validation Protocols / Reports including site discrepancies and deviations investigation / closure. Participate in Site Validation Maintenance Program. Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines. Coordinate with other Engineering functions, End-User and Quality team to ensure the Validation activities are completed as planned and are compliant to user, Lonza standard and regulatory requirements. Review Engineering documents associated with commissioning and validation activities. Evaluate and propose improvement to equipment/system, processes and operations to improve safety and process efficiency. Review & assess Site Change Controls and Validation CAPAs. Participate in Customer / Agency Audits and Inspections as required. Participate in on-job training program for Validation staff and provide training to as required. Any other tasks as and when assigned by manager. Key requirements: Bachelor Degree / Diploma with exposure in the Biopharmaceutical industry. Relevant work experience in Validation / Quality /Manufacturing unit in the pharmaceutical/biotech industry. Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7). Good knowledge and experience of the practical and theoretical requirement of CSV program in a GMP facility. Good oral and written communication skills. Meticulous and Systematic. Team player, with strong focus on safety, quality and timelines. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R57248 Apply Ways to Contact Contact Us Regulatory Support Locations Site Tours Partnering with Us Resources Knowledge Center Meet the Experts Upcoming Events Terms & Conditions Terms and Conditions Legal Disclaimer Privacy Policy California CCPA Notice Transparency in Coverage Lonza.com Company Overview News & Media Investor Relations Sustainability Careers © 2024 Lonza. All rights reserved.