Senior Validation Engineer — Remote Impact Leader

World Courier

Conshohocken (Montgomery County)

Hybrid

USD 110,000 - 160,000

Full time

7 days ago
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Benefits offered by this job

Fully remote work

Job summary

World Courier is seeking a Senior Validation Engineer in Conshohocken, PA with remote options. You will lead validation activities for computer systems, align with 21 CFR Part 11 and GxP, and coordinate with cross-functional teams to ensure compliant validation deliverables.

Required: strong experience in EDMS, validation protocols, RTM, and SQL reporting. This role offers remote work and comprehensive benefits within a health-focused organization.

Qualifications

  • Bachelor’s degree (or foreign equivalent) in Computer Science, Engineering or related field.
  • 5 years of experience with Electronic Document Management Systems.
  • Experience with FDA 21 CFR Part 11 and GxP (GCP and GDP).
  • Proficient in SQL and validation documentation tracking (RTM, VMP, VSR).

Responsibilities

  • Support computer system validation aligning with requirements and policies.
  • Lead gathering of business requirements and system integration design.
  • Prepare and analyze Validation Protocols (VP, IQ/OQ/PQ) and RTM.
  • Interact with cross-functional teams including project managers and operations.
  • Provide training and technical direction for validation efforts.

Skills

Electronic Document Management Systems
Validation testing
Requirements gathering
Quality compliance

Education

Bachelor's degree in Computer Science or Engineering
Master's degree in Computer Science or Engineering

Tools

SQL
KeatGX
HP Quality Center
Team Foundation Server (TFS)

Job description

World Courier is seeking a Senior Validation Engineer in Conshohocken, PA with remote options. You will lead validation activities for computer systems, align with 21 CFR Part 11 and GxP, and coordinate with cross-functional teams to ensure compliant validation deliverables.

Required: strong experience in EDMS, validation protocols, RTM, and SQL reporting. This role offers remote work and comprehensive benefits within a health-focused organization.

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