Computer System Validation Engineer
Full Time • MADISON
Benefits:
- Competitive salary
- Opportunity for advancement
- Training & development
Job Summary
We are seeking a skilled System Validation Engineer to join our team! As a System Validation Engineer, you will be responsible for
validating documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) and responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
validating documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) and responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
Responsibilities
- Validate GMP Lab systems and Equipment
- Identify and escalate, as necessary project risks and issues to the CSVC Manager
- Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs
- Be able to prepare reports on defects and problems that arise during system testing
- Have solid oral and written communication skills and teamwork skills
- Work with business representatives to ensure the test cases reflect business rules and processes
- Fulfills the role of a subject matter expert role for critical quality and compliance GxP end-use applications supporting Animal Health business processes
- Work with business representatives to ensure the test cases reflect business rules and processes
- Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.
Qualifications
- Be a good team player, able to meet deadlines and handle changing priorities
- Have strong judgment capabilities to clarify requirements when necessary
- Have the ability to work with cross functional teams
- Have solid experience working with validated systems
- GMP/Regulated lab, more than 5 years of CSV experience required
- Technical writing Experience
- Highly skilled in Computerized System testing and validation in the healthcare industry
- Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)
- Solid project organizational skills and ability to multi-task with strong analytical problem-solving skills
- Excellent communication including written, verbal, and listening skills
- Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision
- BS in Science or Technical Writing Degree
Compensation: $55.00 per hour
About Us
Founded in 2005, Technoviz is a leading IT Service Provider that offers powerful process-driven, high quality, cost-effective solutions to its esteemed customers with a competitive edge in their respective marketplaces. Built on the principles of entrepreneurial spirit, technical excellence, and superior customer service in response to increasing demand for quality Information Technology services. This evolution has allowed Technoviz to provide a wide range of services as a Complete Solution Provider.
We focus on building long lasting relationships to achieve execution excellence. Our in-depth understanding of business processes across a number of domains coupled with a range of cutting-edge technology skills help us to provide software services to Government, Telecommunications, Manufacturing, Banking & Financial Services, Insurance, Healthcare, Utilities and Technology industries while our Technology Practices provide answers to the most critical challenges prevalent in the current environment.
Technoviz offers a wide range of products developed using state of art technology. We have alliance partnership with leading product companies for providing product solutions to lower the mid cap businesses for Accounting, Payroll, Document Management, Work flow, Point of Sales, Sales & Distribution, Manufacturing etc.
Technoviz achieves excellence through continuous training, learning, innovation, partnership with industry leaders to provide the best value to the customer.
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