Computer Systems Validation Engineer(On-site) || Bethlehem, PA (Local Only)

Overview

Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 4+ month(s)

Skills

csv
LabX
UV-Vis
FTIR

Job Details

Hi,

Hope all is well,

Please revert me with an updated resume if you would like to apply for this role,

Title : Computer Systems Validation Engineer(On-site)

Duration : 2-4 months

Location : Bethlehem, PA

Need local candidate

About the job

We re seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation.

Candidates MUST be able to run all validation activities independently, including the ability to write protocols from scratch.

Key Responsibilities:

  • Lead and execute full-cycle CSV processes across multiple systems, ensuring compliance with regulatory standards.
  • Spearhead system upgrade projects, including migration from Windows 10 to Windows 11.
  • Validate laboratory software and equipment including LabX, UV-Vis spectroscopy, and FTIR software systems.
  • Collaborate with cross-functional teams on the integration of data systems and implementation of audit trails, access controls, and data integrity strategies.
  • Provide guidance and training to internal stakeholders on CSV protocols and lab systems.
  • Document validation activities and maintain accurate records for audits and inspections.

Qualifications:

  • 5 10 years of hands-on experience in Computer Systems Validation, preferably in regulated industries such as pharma, biotech, or medical devices.
  • Demonstrated ability to perform software upgrades and oversee validation
  • Extensive hands-on experience with LabX, UV-Vis spectroscopy, and FTIR software systems
  • Proven ability to write, develop, and execute validation protocols.
  • Proven end-to-end CSV experience, including planning, execution, documentation, and remediation.
  • Strong working knowledge of laboratory equipment software, with hands-on lab experience being a strong plus.
  • Familiarity with data integration frameworks and regulatory requirements around audit trails and access controls.

Thank you

, 110

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About DMS Vision Inc.