Computer Systems Validation Engineer at cGxPServe Bethlehem, PA

cGxPServe; Bethlehem (Northampton County); On-site; USD 85,000 - 110,000; Full time

Job summary

cGxPServe in Bethlehem, PA seeks an experienced Computer Systems Validation Engineer to lead end‑to‑end CSV activities for lab system upgrades and data integrity initiatives.

The role requires hands‑on CSV in regulated environments, including validation planning, execution, and audit-ready documentation, with onsite work through September.

Qualifications

• 5+ years of hands-on CSV in regulated industries such as pharma, biotech, or medical devices.
• Ability to perform software upgrades and oversee validation.
• Hands-on experience with LabX, UV-Vis spectroscopy, and FTIR software.
• Proven ability to write, develop, and execute validation protocols.
• End-to-end CSV experience including planning, execution, and documentation.

Responsibilities

• Lead and execute full-cycle CSV processes across multiple systems.
• Drive system upgrade projects including Windows 10 to Windows 11 migrations.
• Validate laboratory software and equipment like LabX and FTIR tools.
• Collaborate on data system integration, audit trails, and access controls.
• Provide guidance and training on CSV protocols to stakeholders.
• Document validation activities and maintain audit-ready records.

Skills

CSV expertise

Regulatory compliance

Data integrity

Lab software

Documentation

Training & mentoring

Tools

LabX

UV-Vis spectroscopy

FTIR software

Job description

Computer Systems Validation Engineer job at cGxPServe. Bethlehem, PA.

Job Description

• 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.
• 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

• 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 control.