Be an early applicantLess than 25 applicants

Company

PRIMUS Global Services · 6 hours ago

CSV ValidationLead (SAP Applications)

Rahway, NJ

Contract

Remote

Senior Level, Lead/Staff

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AppsConsulting

H1B Sponsor Likely

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Responsibilities

Develop and execute comprehensive Computer System Validation (CSV) plans, protocols (IQ, OQ, PQ), and reports to ensure SAP systems and associated healthcare applications meet regulatory and operational requirements.

Ensure compliance with healthcare industry regulations, including FDA 21 CFR Part 11, GxP, and HIPAA, by validating system functionalities and documentation processes.

Collaborate with cross-functional teams, including IT, quality assurance, and business stakeholders, to define validation requirements and implement risk-based validation strategies.

Perform detailed validation activities, including system testing, user acceptance testing (UAT), and documentation of test results, ensuring systems function as intended in a healthcare environment.

Identify and resolve validation issues, conducting root cause analyses and implementing corrective actions to maintain compliance and system reliability.

Provide training and guidance on CSV processes to stakeholders, ensuring understanding and adherence to validation standards and best practices.

Stay updated on healthcare regulations and validation trends, advising on improvements to validation strategies and ensuring the organization's systems remain compliant and efficient.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Computer System ValidationFDA 21 CFR Part 11GxPSAP validationHIPAA complianceRisk-based validationSAP healthcare modulesUser acceptance testingRoot cause analysisTraining on CSV processesCollaboration skills

Required

Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements.

Proficiency in validating SAP systems and associated healthcare applications, including creating and executing validation plans, protocols, and reports (IQ, OQ, PQ).

In-depth knowledge of healthcare regulatory compliance, including HIPAA and other industry standards, to ensure validated systems meet operational and legal requirements.

Experience in risk-based validation approaches, focusing on critical system functionalities and maintaining compliance while optimizing validation efforts.

Strong understanding of SAP healthcare modules (e.g., MM, SD, FICO, EHS) and their integration with other systems to design effective validation strategies.

Excellent problem-solving skills to identify, document, and resolve validation issues, ensuring systems operate reliably and meet compliance standards.

Effective communication and collaboration skills to work with cross-functional teams, including quality assurance, IT, and business stakeholders, to ensure successful validation processes.

Ensure compliance with healthcare industry regulations, including FDA 21 CFR Part 11, GxP, and HIPAA, by validating system functionalities and documentation processes.

Collaborate with cross-functional teams, including IT, quality assurance, and business stakeholders, to define validation requirements and implement risk-based validation strategies.

Perform detailed validation activities, including system testing, user acceptance testing (UAT), and documentation of test results, ensuring systems function as intended in a healthcare environment.

Identify and resolve validation issues, conducting root cause analyses and implementing corrective actions to maintain compliance and system reliability.

Provide training and guidance on CSV processes to stakeholders, ensuring understanding and adherence to validation standards and best practices.

Stay updated on healthcare regulations and validation trends, advising on improvements to validation strategies and ensuring the organization's systems remain compliant and efficient.

Company

PRIMUS Global Services

Glassdoor

3.8

Primus Global Services provides staff augmentation, IT consultation, data analytics, ERP and application modernization services.

Founded in 2002

Irving, Texas, USA

1001-5000 employees

https://primusglobal.com/

H1B Sponsorship

PRIMUS Global Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (20)

2022 (20)

2021 (32)

2020 (73)