Computer System Validation Engineer
- 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.
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.
- 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
Average salary estimate
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