Onsite CQV & Validation Engineer - GMP

Piper Companies

Clayton (NC)

On-site

USD 130,000 - 160,000

Full time

4 days ago
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Benefits offered by this job

Health, Vision, and Dental benefits
PTO and paid holidays
Sick leave
2-year contract with potential for ext

Job summary

Piper Companies seeks a Validation Engineer for a leading pharmaceutical manufacturer in Clayton, NC. This role is onsite in Clayton, NC and targets an experienced validation professional with expertise supporting GMP-regulated environments across manufacturing operations, facility systems, quality control laboratories, and computerized systems.

You will lead commissioning, qualification, and validation activities for facility systems, manufacturing equipment, and supporting utilities.

Qualifications

  • 5+ years of validation experience in regulated manufacturing environments.
  • Hands-on CQV for facility systems, processes, or computerized systems.
  • Knowledge of aseptic processing, filling, packaging, warehouse validation, or QC lab validation.
  • Familiarity with cGMP, FDA guidance, GAMP 5, and data integrity requirements.
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline.

Responsibilities

  • Lead commissioning, qualification, and validation activities for facility systems, equipment, and utilities.
  • Develop, execute, and review validation documentation (IQ/OQ/PQ, plans, risk assessments, final reports).
  • Support validation across aseptic formulation, filling, packaging, warehouse, QC labs, and computerized systems.
  • Collaborate with engineering, QA, manufacturing, IT, and operations to meet timelines and regulatory expectations.
  • Investigate deviations and implement corrective actions to maintain compliance.

Skills

CQV experience
GMP knowledge
Regulatory compliance

Education

Bachelor's degree in Engineering/Life Sciences/CS

Job description

Piper Companies seeks a Validation Engineer for a leading pharmaceutical manufacturer in Clayton, NC. This role is onsite in Clayton, NC and targets an experienced validation professional with expertise supporting GMP-regulated environments across manufacturing operations, facility systems, quality control laboratories, and computerized systems.

You will lead commissioning, qualification, and validation activities for facility systems, manufacturing equipment, and supporting utilities.

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