Overview
Skills
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
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