Validation Analyst

Validation Analyst Thermo Fisher Scientific - 3.4 Middleton, WI Job Details Full-time 1 day ago Qualifications System design Mid-level Bachelor's degree Requirements analysis Requirements gathering Project stakeholder communication Test Planning (Quality assurance practices) Documentation reviews Engineering validation SDLC Full Job Description Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role Participates as a validation representative at project team meetings and completes assigned action items. Provides 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. Provides 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. Reviews 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. Executes 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. Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs. Participates 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.