Pharma Validation Engineer – Onsite, Clayton

Piper Companies

Clayton (NC)

On-site

USD 98,000 - 112,000

Full time

4 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401K

Job summary

Piper Companies is seeking a Validation Engineer for a long-term onsite contract based in Clayton, NC. The role supports a diverse project portfolio across manufacturing, facilities, laboratory, automation, and quality systems while ensuring GMP compliance and FDA-aligned validation practices.

Responsibilities include IQ/OQ/PQ execution, documentation, change control, and collaboration with cross-functional teams to upgrade equipment, facilities, and automation systems.

Qualifications

  • Experience in validation within pharmaceutical manufacturing or regulated environments.
  • Ability to author and execute IQ/OQ/PQ and related validation documents.
  • Familiarity with computerized systems validation and associated platforms.

Responsibilities

  • Develop, revise, and maintain validation lifecycle documentation (validation plans, specifications, risk assessments, traceability matrices, reports, change controls).
  • Author and execute qualification activities (IQ/OQ/PQ, design reviews, commissioning support, process validation).
  • Collaborate with project managers, engineering, quality to support upgrades and modernization.
  • Investigate deviations, assess impacts, document corrective actions, support change management.
  • Ensure validation deliverables meet GMP and FDA regulatory requirements and GAMP 5, Annex 15.

Skills

Validation experience
GMP compliance
FDA regulations
Risk assessment
Documentation & change control
Qualification protocols
Qualification execution

Education

Bachelor’s degree in Engineering/Life Sciences/Computer Systems

Tools

SCADA
PLCs
PAS-X
LMES
Veeva
HP ALM/TIMS

Job description

Piper Companies is seeking a Validation Engineer for a long-term onsite contract based in Clayton, NC. The role supports a diverse project portfolio across manufacturing, facilities, laboratory, automation, and quality systems while ensuring GMP compliance and FDA-aligned validation practices.

Responsibilities include IQ/OQ/PQ execution, documentation, change control, and collaboration with cross-functional teams to upgrade equipment, facilities, and automation systems.

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