Job Title: Sr. Computer System Validation Engineer
Location: St, Joseph, MO
Type: Contract
 
Responsibilities Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment 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. 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. 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. 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.  
Requirements 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. Ability to multi-task. Must have 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
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
 

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.