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Computer System Validation Csv Remote Jobs in Pennsylvania

Deloitte

System Test and Validation Lead

Pittsburgh, PA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent ... This compensation range is specific to a remote role and takes into account the wide range of ...

Deloitte

System Test and Validation Lead

Pittsburgh, PA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent ... This compensation range is specific to a remote role and takes into account the wide range of ...

Deloitte

System Test and Validation Lead

Pittsburgh, PA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent ... This compensation range is specific to a remote role and takes into account the wide range of ...

Motorola

PremierOne Remote System Admin

Indiana, PA · Remote

$80K - $90K/yr

... for Onsite System Administrators on extended leave, providing remote backfill coverage when ... Ensure that reported PremeirOne CAD or RMS incidents/problems are documented, analyzed, validated ...

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Computer System Validation Csv Remote information

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

What is the difference between Computer System Validation Csv Remote vs Computer Validation Specialist?

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
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Computer System Validation Csv Remote jobs near you
6420 - Senior CSV Engineer / Senior Validation Engineer

6420 - Senior CSV Engineer / Senior Validation Engineer

Verista, Inc.

King Of Prussia, PA • Remote

$104K - $142K/yr

Other

Posted 3 days ago

Job description

Senior Validation Engineer Responsibilities:

  • Lead SAP validation strategy and CSA/CSV activities for SAP S/4HANA, ECC, and integrated GxP systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Annex 11 requirements
  • Provide oversight and approval of validation lifecycle deliverables, including URS, risk assessments, validation plans, test protocols, traceability matrices, and validation summary reports
  • Support SAP integrations with enterprise applications such as MES, LIMS, Veeva, TrackWise, and other regulated systems, ensuring data integrity and end-to-end process compliance
  • Review change controls, impact assessments, system enhancements, and upgrades to maintain validated state and inspection readiness
  • Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring alignment with SDLC and quality procedures
  • Monitor validation KPIs, drive continuous improvement initiatives, and provide SME support during audits, inspections, and cross-functional project activities

Job Requirements:

  • 5+ years in Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
  • Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance
  • Strong experience with SAP or enterprise platform validation in GxP environments
  • Proven ability to review/approve validation documentation and oversee testing governance
  • Experience working remotely with global stakeholders
  • Experience supporting S/4HANA upgrades or large enterprise transformation programs
  • Familiarity with ALCOA+ documentation principles and quality governance frameworks
  • Prior lead-level CSA/CSV role

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