Validation Engineer - 175655 - 176205

Piper Companies; Clayton (NC); Vor Ort; USD 130.000 - 160.000; Vollzeit

Benefits dieser Stelle

Health, Vision, and Dental benefits

PTO and paid holidays

Sick leave

2-year contract with potential for ext

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CQV experience

GMP knowledge

Regulatory compliance

Ausbildung

Bachelor's degree in Engineering/Life Sciences/CS

Jobbeschreibung

Piper Companies is seeking a Validation Engineer for a leading pharmaceutical manufacturing organization in Clayton, NC. The Validation Engineer role requires working fully onsite in Clayton, NC. The Validation Engineer role is ideal for an experienced validation professional with expertise supporting GMP-regulated environments across manufacturing operations, facility systems, quality control laboratories, and computerized systems.

Responsibilities of the Validation Engineer include:

• Lead commissioning, qualification, and validation activities for facility systems, manufacturing equipment, and supporting utilities within GMP-regulated operations.
• Develop, execute, and review validation documentation including IQ/OQ/PQ protocols, validation plans, risk assessments, and final summary reports.
• Support validation efforts across aseptic formulation and filling, device assembly and packaging, warehouse operations, QC laboratories, and computerized systems.
• Partner with engineering, quality assurance, manufacturing, IT, and operations teams to ensure validation deliverables meet project timelines and regulatory expectations.
• Investigate protocol deviations, implement corrective actions, and maintain compliance with FDA, EU GMP, and industry validation standards.

Requirements of the Validation Engineer include:

• 5+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Hands-on experience supporting commissioning, qualification, and validation (CQV) projects for facility systems, manufacturing processes, or computerized systems.
• Knowledge of aseptic processing, filling operations, packaging systems, warehouse validation, and/or QC laboratory validation.
• Familiarity with cGMP regulations, FDA guidance, GAMP 5, and data integrity requirements.
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.

Compensation for the Validation Engineer include:

• $130,000 - $160,000 annually
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
• 2-year contract engagement with potential extension opportunities.

This job opens for applications on 10/16/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: validation engineer, CQV engineer, commissioning engineer, qualification engineer, aseptic manufacturing, GMP, facility systems, IT systems validation, computer systems validation, CSV, QC validation, warehouse validation, packaging validation, pharmaceutical manufacturing

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