Tosoh America, Inc. serves as the parent and holding company to the 6 US subsidiaries of Tosoh Corporation and provides Human Resources, Financial/Accounting, and Information Technology support services to the North American companies collectively known as Tosoh Group America.
Our group of companies, are engaged in advanced technology fields ranging from the manufacture and sale of semiconductor and solar materials, to the sale of medical diagnostic instruments, high performance liquid chromatography (HPLC) and bio-separation media, and a wide range of other chemicals and advanced materials. These operations encompass manufacturing, distribution and sales, regulatory and technical support as well as equipment servicing, serving customers in the IT and high-tech, chemical, pharmaceutical and medical industries.
Join us for the chance to work with an amazing, experienced, and talented team at Tosoh America, Inc. We have an opening for a Computer Systems Validation Analyst in our IT Department. This position is located at our Grove City, OH headquarters. The successful candidate will be responsible for lifecycle management of all PCs and laptops The successful candidate will be responsible for writing qualification and validation documentation relating to the business applications and infrastructure used by an FDA regulated company. This position will be accountable for scheduling, tracking, reporting and achieving project deadlines related to software and environmental changes that affect the FDA regulated company. They will also perform planned periodic reviews of systems and ensure implementation of any remedial actions necessary.
Bachelor's degree in a scientific field, Computer Science, MIS, Engineering, or related discipline.
Three to five years' CSV experience in an FDA regulated environment such as pharmaceuticals, medical devices or diagnostic testing related experience preferred.
Knowledge of Computer System Validation including GAMP5 and 21CFR Part 11 requirements
Proficiency with Microsoft Office 2010 and SharePoint 2010, and later applications
Writing and maintaining documentation following Good Documentation Practices (GDP) relating to computer system changes, system validations, system inventories, documenting system parameter changes pre and post changes, executing test plans, and gathering user requirements
Exposure to HIPPAA, GDPR, and general privacy policies would also be beneficial.
In addition to the above skills, the successful candidate must possess a positive team oriented attitude, excellent written and oral skills, and a very professional demeanor.
Tosoh America, Inc. (Grove City, OH) serves as the parent company to the US subsidiaries of Tosoh Corporation and provides Human Resources, Financial/Accounting, and Information Technology support services to 6 North American companies.
TSAM is an Equal Opportunity Employer M/F/Disabled/Veterans.
Tosoh Group America