Validation Engineer

Career Category Information Systems 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 product 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 work with clients to develop validation plans 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 configurations 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 Ability to manage multiple priorities successfully Strong presentation and public speaking skills Strong verbal and written communication skills High degree of initiative and self-motivation What you can expect of us As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture we ll support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now and make a lasting impact with the Amgen team careers amgen com As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request accommodation