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From Home Computer System Validation Jobs in New Jersey

CSV Consultant

Somerville, NJ · On-site

$45 - $50/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Flexible work from home options available.

Bachelor's Degree in computer science, math or science with a minimum of 10 year's experience working in relevant field for associated (System Validation, Quality Assurance, Testing Lead or related ...

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From Home Computer System Validation information

What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?

AspectFrom Home Computer System ValidationFrom Home Quality Assurance Specialist
CertificationsGxP validation, 21 CFR Part 11ISO 9001, QA certifications
Work EnvironmentPrimarily remote, focused on system testing and validationRemote or onsite, focused on process audits and compliance
Industry UsagePharmaceutical, biotech, healthcareManufacturing, software, healthcare
Job FocusEnsuring computer systems meet regulatory standardsEnsuring overall quality processes and compliance

From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

Is computer system validation a good field?

Computer system validation is a specialized field within quality assurance and regulatory compliance, primarily in industries like pharmaceuticals and healthcare. It involves ensuring that computer systems meet regulatory standards through documentation, testing, and validation protocols, often requiring knowledge of GxP regulations and validation tools. The field offers steady demand and opportunities for certification and skill development.

What are the most commonly searched types of Computer System Validation jobs in New Jersey?

The most popular types of Computer System Validation jobs in New Jersey are:

What are popular job titles related to From Home Computer System Validation jobs in New Jersey?

For From Home Computer System Validation jobs in New Jersey, the most frequently searched job titles are:

What job categories do people searching From Home Computer System Validation jobs in New Jersey look for?

The top searched job categories for From Home Computer System Validation jobs in New Jersey are:

What cities in New Jersey are hiring for From Home Computer System Validation jobs?

Cities in New Jersey with the most From Home Computer System Validation job openings:

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Princeton, NJ • On-site

Other

Posted 3 days ago

New


Job description

Job Description:
  • In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:
  • pply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
  • Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
  • Facilitate risk assessments to identify validation deliverables and project requirements.
  • Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
  • Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
  • nalyze validation data and troubleshoot issues in collaboration with technical teams.
  • Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:
  • Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
  • Hands-on experience in validating computerized systems.
  • Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
  • bility to work effectively in a dynamic, cross-functional team environment.
  • Proven expertise in applying data governance measures and creating impactful data visualizations.
  • Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
  • Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.