Test Engineer InfoMedics
THIS JOB HAS EXPIRED General Position Summary:
The Test Engineer?s role will be responsible for delivering and ensuring that all aspects of new and existing systems are validated and maintained in a validated state to SDLC requirements. You must have the analytical, organizational, communication and writing skills. You will need to be a self-starter who can work with limited direct supervision and drive to tight timelines with a sense of urgency. Training will be provided to candidates who do not have experience in Validation and Compliance.
Essential Job Functions:
A comprehensive review, creation, and execution of all documents related to computer system validation activities including but not limited to:
Validation Master Plans
Test Protocols and Use cases
Validation Protocols including IQ (Installation Qualification), OQ (Operational Qualification) and PQ?s (Performance Qualification)
Validation Summary Reports
Standard Operating Procedures
Defining the validation and testing environment, validations steps and success criteria
Represent Validation and support QA activities in both internal audits and external audits.
Analyzing and resolving validation problems.
Create automated functional tests.
Develop and implement policies needed for an effective validation program ensuring compliance with FDA regulations and guidance documents including GxPs, PDMA and 21 CFR Part 11 and industry accepted pharmaceutical practices.
Provide guidance and support to Development, SQC, Infrastructure and Solutions Design groups in creating applicable documents to maintain the system in Compliance with FDA regulations and guidance documents including GxPs, PDMA and 21 CFR Part 11 and industry accepted pharmaceutical practices.
Working with Software Development Team and other departments as needed on changes to code wherever is needed to meet business and compliance criteria.
Work with onshore/offshore teams
We are looking for a software test engineer who could perform as a Validation Engineer. Training will be provided. Requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and Experience:
BS (or equivalent)
2 ? 5 (max) years industry experience in software testing of internet based and mobile applications
Excellent working knowledge of MS Office particularly, Excel and Word
Excellent oral and written skills
Knowledge of practices and types of software testing
Experience with automated testing tools such as Selenium
Experience in database testing and creating and executing SQL queries
A commitment to quality and a thorough approach to work
Ability to effectively coordinate tasks and activities with others in a productive manner.
Experience working with onshore/offshore teams
Ability to work as a team member
Ability to work creatively and analytically in a problem-solving environment
Time management skills
Experienced in the planning and execution of a test plan.
Ability to work with and retain information of a confidential nature
Familiarity with FDA regulations including GxPs, Part 11 and PDMA FDA regulations would be a plus
Ability to read, analyze, and interpret common scientific and technical journals. Ability to draft a response to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to draft articles for publication that conform to prescribed style and format. Demonstrated ability to communicate technical issues to a wide range of audiences.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio and percent and to draw and interpret bar graphs. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to create and manage budgets. Ability to read various statistics.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and analyze several abstract and concrete variables.
There are no supervisory responsibilities.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel. The employee is also frequently required to talk and hear. The employee is frequently required to stand, walk, climb, stoop, and/or kneel. Specific vision abilities required by this job include close vision and ability to adjust focus.
||Reading, MA |
THIS JOB HAS EXPIRED