Sr. Validation Engineer

Job Description

What you will do In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain aligned with industry standards and align 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 domain 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. Doctorate degree OR Masters degree and 4 to 6 years of Life Science/Biotechnology/ Pharmacology/Information Systems experience OR Bachelors degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/ Biotechnology/Pharmacology/ Information Systems experience Preferred Qualifications: 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 Proven leadership skills with the ability to multitask and lead multiple validation projects Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology. 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 (HP) 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. Good-to-Have 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 enterprise CDS platform software (Empower/Chromeleon/Unicorn) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Ability to work effectively with global, virtual teams. Excellent analytical and solving skills. Ability to prioritise successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation.