Validation Engineer

Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Validation Engineer You will play a pivotal role in ensuring compliance across the Process Development and Manufacturing . The Validation Engineer will assist the Benchtop p roduct team with all aspects of the computer validation process across the Operations footprint. Role Description: Let’s do this. Let’s change the world. In this vital role you will be part of the Benchtop Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain compliant with industry standards and comply with all regulatory requirements. Roles & Responsibilities: Advising clients on how to meet compliance requirements using a risk-based approach . Develop validation documentation and standard operating procedures for various GxP applications. Develop test protocols that thoroughly test business requirements. Provide test execution oversight and assist with deviation recommendations as required , w ork with client s to develop validation plan s to ensure that, at the end of the project, the system meets GxP requirements . Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required Development of test / validation scripts based on software design and configuration s. Develop IQ/OQ scripts as required . Basic Qualifications: Master’s degree with 8 - 12 years of experience in validation/regulatory or related field OR Bachelor’s degree with 10 - 14 years of experience in validation/regulatory or related field OR Functional Skills: Must-Have Skills: Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice . Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. Expertise with ALM testing and ALM software Expertise in use – Veeva (all modules – CDocs , QMS, RIM, DocuSign , etc ) Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance. Preferred Skills: Ability to work independently, excellent problem solving and professional written communications skills. Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets , Salesforce, Tableau a plus FDA Audit experience a plus & working with regulatory agencies Experience with instrument qualifications (IQ/OQ), validation plans , regulated workflows. Soft Skills: Excellent leadership and team management skills . Strong transformation and change management experience. Ability to work effectively with global, virtual teams . Excellent analytical and troubleshooting skills .