Computer System Validation Coordinator

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

• Bachelor’s Degree or related work experience,required.

• At least 1-3 years of experience in a direct CSV role,required.

• At least 2 years of experience in a regulated environment,required.

• Working knowledge in creating test protocols for Salesforces in a regulated environment

• Experience delivering CSV projects within the healthcare industry.

• Experience in working with a structure Project Management Office (PMO) to deliver projects to industry best practice.

• Good knowledge of GAMP

• Good working knowledge of Annex 11 and 21CFR Part 11.

• Good knowledge of business enterprise computer systems.

• Experience working with hardware and software in a controlled (qualified) environment.

• Experience with Pharmaceutical Quality Systems including change control, deviation, CAPAs, and document management (GDP).

• Team player with the ability to communicate across functional departments and divisions.

• Project management, process design experience.

• Ability to challenge the status quo and propose process improvements

• Highly motivated

• Critical thinking and problem solving skills

• Strong organizational skills, detail oriented with ability to multi task in a very fast paced environment

• Exceptional written and verbal communication skills

• High computer proficiency with the Microsoft Office package, consisting of Outlook, Word, Excel, and PowerPoint. Microsoft Visio and/or Adobe Acrobat experience a plus.

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: https://inizio.health/

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.