Computer Systems Validation Specialist

This position may be located in Europe or the United States. - Candidates located in EU, please apply to job# 230885 About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. About the Industry: At Gore, our global support teams bring together extensive knowledge and collaborate closely to support our diverse portfolio of products that solve complex problems and perform in the most demanding environments.  Learn more at gore.com/products/industries About the Role: We are looking for a Computer Systems Validation (CSV) Specialist to join our team. In this role, you will be responsible for ensuring the fitness-for-use of W.L. Gore’s computer systems. The CSV Specialist will be responsible for working with functions throughout the organization to successfully carry out the computer system validation strategy through a risk-based approach that ensures the quality and integrity of data over the entire system lifecycle. This is a remote position, and you can work from home in most locations within the United States.* Responsibilities: - Ensure that the quality system elements necessary to achieve and maintain compliance across multiple businesses and varied regulatory requirements, are established and activities related to computer systems/software testing are controlled via these elements - Ensure that test cases are documented and executed following the requirements set forth by procedures and external requirements - Work with appropriate teams to establish quality expectations related to software quality assurance and computer system validation - Collaborate with stakeholders in the preparation of software and hardware specification documents and test plans - Author, review and/or approve system change, configuration management, and supporting documentation activities - Participate in external/internal computer system/software audits - Support defect resolution - Support and monitor the qualification of Information Technology Infrastructure Platforms

Qualifications:

Required Qualifications: - Minimum 5 years of experience in a computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry - Demonstrated experience in software quality assurance processes, SDLC methodology, supplier quality management, change management, documentation, verification, periodic review, and validation techniques - Understanding of current software quality-assurance techniques and software industry standards and their impact on internal procedures, and software quality - Excellent written and oral communication skills - Highly motivated - Demonstrated ability to work in a dynamic team environment - Ability to handle multiple projects and priorities with competing resources - Ability to communicate clear direction, commitments, and alignment - Ability to travel up to 10% Desired Qualifications: - Bachelor’s degree in an applicable science - Experience with ALM software - Experience with ERP, Product Lifecycle Management Systems, and/or Manufacturing Execution Systems *Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. Note: For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only). What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect. Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description. Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.) Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact