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Validation Analyst II
Validation Analyst II-March 2024
Remote
Mar 28, 2026
About Validation Analyst II

  Job Description

  Performs analysis of new business system development and system improvements. Conducts analysis, design, evaluation, modification, testing and implementation of Enterprise-wide systems (e.g., finance, human resources, payroll, supply chain, client relationship management) across functional areas. Performs studies of potential electronic data processing applications and prepares design proposals to

  reflect cost, time and alternative actions to satisfy existing and future needs of the corporation. Tests and evaluates plans and protocols for of system performance. Conducts analysis of systems specifications and uses the latest analysis/diagramming tools to represent business/technical processes. Develops conversion and system implementation plans. Prepares and obtains approval of system and

  programming documentation. Recommends changes in development, maintenance and system standards. Coordinates system upgrade activity.

  Participates as a validation representative at project team meetings and completes assigned action items.

  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.

  Manages assignments to meet deadlines and produce high quality deliverables.

  Works with leadership to address any validation issues arising from client or internal audits.

  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

  Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

  Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

  Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

  Exercises judgment within defined procedures and practices to determine appropriate action.

  Business Contacts are internal to the company and with external customer/vendor contact on routine matters. Builds productive internal / external working relationships.

  Qualifications:

  Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years

  Bachelor's degree or equivalent and relevant formal academic / vocational qualification

  Knowledge, Skills and Abilities:

  Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others

  Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction

  Strong attention to details and problem-solving skills

  Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines

  Positive attitude, enthusiasm toward work, and the ability to work well with others

  Solid understanding of life sciences operational processes and terminology and solid understanding of the software development life cycle (SDLC)

  Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced

  Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans.

  Ability to assess the cause of test failures

  Ability to attain, maintain, and apply a working knowledge of procedures and processes

  Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

  Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team

  Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

  Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.

  Requires multiple periods of intense concentration.

  Frequently interacts with others to obtain or relate information to diverse groups.

  Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.

  Hours vary based on project deliverables. May be early in the morning or later at night.

  Regular and consistent attendance.

  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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