The Associate Validation Analyst provides 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 activities. Facilitates the validation process as well as implementation of system upgrades, including duties of guiding, testing, supporting the introduction, and ongoing support of software systems. Participates as a member of the Project teams where needed and helps provide direction on future enhancements to the system. Responsibilities may include:
Serves as 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 the validated systems per SOP.
Reviews PQ and change control documentation with the IT Project Manager per SOP.
Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Updates test scripts where required based on requirement changes or upgrades in application functionality.
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 data within the testing environment, sufficient to accurately test software functionality.
Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support and maintenance is provided.
Minimum Required Education and Experience:
Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities Fundamental training, knowledge and experience with systems or software validation processes
Required Knowledge, Skills and Abilities:
Client focused approach with strong interpersonal skillsStrong oral and written communication skillsStrong attention to detail Ability to adapt and adjust to changing prioritiesCompetent with MS Word, MS Excel, MS Power Point Working Conditions:Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Demands:Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.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. Frequently interacts with others to obtain or relate information to diverse groups. 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. 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 multi-task. Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
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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