MES Recipe Modeler 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 MES Recipe Modeler United States, Portsmouth (New Hampshire) 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. This entry level position is responsible for consistently delivering accurate and high-quality process electronic Batch Records (eBR) to Manufacturing in a timely manner for a number of different customer projects. Key responsibilities: Development and revision of electronic Batch Record (eBR) configuration, coordination of the delivery of other support documents for approval of eBRs, participation in project team meetings to coordinate project schedules and alignment of groups in regards to the writing, review, and approval of process of eBRs. Effectively work with all Lonza departments to provide technical support, expertise and leadership in overseeing eBRs are consistently generated and delivered to Manufacturing in a timely manner with a high level of quality that ensures the promotion of Right-First-Time operations on the manufacturing floor. Manage eBR review comments, answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the minimal aid of document owners, coordinate delivery timelines for eBR support documents for approval of batch records Assist with testing and validation of eBRs, operations and electronic work instructions. Manage equipment configuration within the MES System. Includes adding and updating equipment configuration as required. Assist senior staff in the execution of process change controls and responses to CAPAs. Conduct basic troubleshooting on eBRs and MODA development environment. Support the approval and roll out of new/revised SOPs as part of paper-to-electronic batch record conversion. Perform other duties as assigned Key requirements: High School Diploma or Equivalent. At least 1 year of experience in Biotech manufacturing or technical writing experience Manufacturing process knowledge preferred. Working knowledge of GMP/Biotechnology manufacturing background preferred. Experience in documentation creation preferred.  Practical knowledge and application of Operational Excellence/Lean tools beneficial. Practical experience with Microsoft suite a plus. Ability to manage multiple priorities. 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. 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.   Reference: R59393 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. Cookie Settings