What are the responsibilities and job description for the Computer System Validation Coordinator position at Inizio Engage?
The CSV Coordinator will be responsible for the generation and execution of CSV protocols and reports in line with GxP, industry best practice and company policies. In addition, for non GxP systems, act as the test lead and prepare the test protocols and reports as required.
What's in it for you?
Competitive compensation
Excellent Benefits - accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and bonding time benefits, employee discounts / promotions
Generous performance-driven Incentive Compensation package
Competitive environment with company wide recognition, contests, and coveted awards
Exceptional company culture
Recognized as a Top Workplace USA 2021
Awarded a "Great Place to Work" award in 2022 and 2023
Fortune Best Workplaces in Biopharma 2022
What will you be doing?
- Responsible for the generation and execution of validation protocols, and reports.
- Support IT COE with assessment of all new global IT projects to ensure GxP requirements are understood and agreed at project initiation phase.
- Generation of validation protocols, testing protocols, reports, and procedures generated by the company or external vendors.
- Manage the testing process for Cloud base platform and report progress to respective project leads and CSV Lead in a timely manner.
- Support client audits, internal audits, and regulatory inspections as CSV subject matter expert.
- Safeguard patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA).
- Other duties assigned as needed.
What do you need for this position?
About Inizio Engage
Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need.
We believe in our values : We empower everyone / We rise to the challenge / We work as one / We ask what if / We do the right thing , and we will ask you how your personal values align to them.
To learn more about Inizio Engage, visit us at :
Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records.
Inizio Engage is an equal opportunity employer M / F / V / D. We appreciate your interest in our company, however, only qualified candidates will be considered.
