Senior Validation Engineer – Onsite Pharma (Clayton, NC)

ZP Group

Georgia

On-site

USD 96,000 - 110,000

Full time

4 days ago
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Benefits offered by this job

Medical/dental/vision benefits
401(k) plan
Long-term contract

Job summary

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical client in a GMP environment, focusing on validation and qualification across systems and processes. The role requires technical leadership in validation strategy and change management, with hands-on execution in IQ/OQ/PQ, investigations, and documentation.

The position is a long-term W2 contract, onsite in Clayton, NC, offering visibility on complex projects, cross-functional collaboration, and

Qualifications

  • Bachelor’s degree in Engineering, CS, or related field; equivalent experience considered.
  • 7+ years of validation/quality experience in pharma or medical devices.
  • GMP knowledge and validation lifecycle expertise.
  • Experience with 21 CFR Part 11, GAMP5, FDA regs and ICH guidance.

Responsibilities

  • Prepare, execute, analyze IQ/OQ/PQ protocols and reports.
  • Own Change Requests related to validation activities.
  • Author/Review Validation Plans, PQMPs, protocols, reports.
  • Lead validation activities for direct-impact systems and processes.
  • Perform compliance reviews and technical approvals of docs.
  • Lead investigations and root-cause analyses for deviations.
  • Ensure validation activities comply with regulatory requirements.
  • Support FAT, SAT, commissioning and startup activities.

Skills

GMP knowledge
Validation lifecycle
Root cause analysis
Project leadership
Cross-functional collaboration
Regulatory standards
Documentation skills
Change control

Education

Bachelor’s degree in Engineering/CS/related
Master’s degree preferred

Job description

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical client in a GMP environment, focusing on validation and qualification across systems and processes. The role requires technical leadership in validation strategy and change management, with hands-on execution in IQ/OQ/PQ, investigations, and documentation.

The position is a long-term W2 contract, onsite in Clayton, NC, offering visibility on complex projects, cross-functional collaboration, and

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