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Computer Systems Validation Engineer

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Job Location drjobs

Bethlehem - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Description:

  • Were 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.
  • This is a short-term contract assignment running through September and requires individuals to work onsite.

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.

Requirements:

  • 510 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 control.

Additional Information :

All your information will be kept confidential according to EEO guidelines.


Remote Work :

No


Employment Type :

Contract

Employment Type

Contract

Company Industry

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