Seagen

IT Business Analyst III

Corporate Functions - Bothell, Washington

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The Business Analyst III (GXP Test BA) specializes in the preparation and execution of Computer Systems Validation processes, focusing on testing and the creation of other validation deliverables. Assists in identifying, evaluating, and developing requirements specifications. Executes unit, integration, and acceptance testing for systems to ensure they meet business needs.

The IT Business Analyst GXP Tester is a member of the IT Business Applications Management team. This role has Pharma/Biotech domain knowledge and is responsible for functional business analysis activities including: driving requirement gathering, testing, developing and executing validation plans as well as lifecycle management functions. This role collaborates closely with business stakeholders, Quality, and IT, and acts as a validation subject matter expert where appropriate. This role provides ongoing process improvement, system enhancement, and support post-implementation.

Principal Responsibilities:

• Experience in GxP validation testing
• Able to author validation plan and risk assessment documents in collaboration with Quality and IT CSV functions
• Able to guide the teams on 21 CFR part 11 assessment and compliance verification
• Working experience with Agile framework / validation testing in agile
• Develop, execute, and document validation for computer system implementation and configuration changes according to SDLC
• Own and maintain processes, documentation, and material while remaining compliant with regulatory guidelines
• Lead issue troubleshooting, resolve root cause, and update process and documentation to avoid similar future scenarios
• Manage activities and accountable for the outcome for complex and highly visibility efforts
• Lead or advise in validation activities and the creation of templates, process improvement
• Identify opportunities to streamline and scale processes that aligns with organizational goals
• Develop project plans for validation activities and ensure plans are delivered
• Develop risk-based approaches to systems validations
• Writing Test Plans, Test Scenarios, Test Data and Test Case review based on Functional Requirements
• Track and Report Defects/Issues
• Experience across System, Integration, Functional, UAT, and End to End testing
• Good working knowledge in all the phases of project development life cycle of different methodology like waterfall, iterative and agile scrum methodology
• Analyze test results, tracking issues/defects, bug reporting and resolving tickets to closure
• Author or review computer system validation documentation - such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)
• Provide Computer Validation tester/reviewer training as needed

Required Qualifications:

• Extensive technical knowledge of validation and current validation approaches and practice
• Good knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations, and standards
• Experience with of FDA and EU computer systems validation and associated regulations (cGMP, GLP, ICH, GAMP, DI, Part11, Annex 11)
• Demonstrated technical understanding of application architecture including various technologies and complexity such as SaaS solutions, web applications, repositories, relational databases, and reporting
• Excellent communication skills, including the ability to interface and influence internal and external partners at multiple organization levels
• Strong interpersonal and negotiation skills, with a high degree of self-motivation, and ability to work independently with minimal supervision
• Ability to proactively plan, organize, deliver with limited oversight, prioritize, and quickly adapt to changing situations
• Experience on release management for IT applications with a specific focus on SaaS applications
• Excellent technical writing skills and ability to document all work in an accurate and timely manner

Preferred Qualifications:

• Experience with Veeva Vault product suite
• Experience with ALM and automated testing
• Familiarity with biotech/pharmaceutical business processes and applications
• Familiarity with GxP and ICH regulations and 21CFR, Part 11

Education:

• Bachelor’s Degree with 5+ years of BA and CSV experience or Master’s degree with 3+ years of BA and CSV experience
• Preferred - Master’s in business and Administration (MBA)

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 04/29/2022