Middleton, WI, 53562, USA
5 days ago
Validation Engineer
Description: The Validation Analyst provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing support of software systems. They will: - Participate as a validation representative at project team meetings and completes assigned action items. - Provide direction for future releases to software systems; reviews and approves/rejects change requests. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints. - Provide validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases and validation summary reports, and executes test cases. - Review and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP. - Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. - Execute test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits. - Manage assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs. - Participate in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation. They will be responsible for things like: - Drafting Documentation: Change Controls, Validation Strategy documents, Risk Assessments, IOPQ, User Requirements, Summary Reports - Hosting vendors during installation activities - Executing testing and working with immediate project team on validation related activities About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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