Onsite CQV Validation Engineer — GMP Manufacturing

Zachary Piper Solutions; Clayton (NC); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Piper Companies seeks a Validation Engineer to support GMP-regulated operations at a Clayton, NC site. You will lead CQV activities for facility systems, equipment, and utilities in a fully onsite role.

The role requires 5+ years CQV experience, knowledge of aseptic processing, FDA guidance, and collaboration with engineering, quality, IT, and manufacturing to meet regulatory timelines and quality objectives. A Bachelor's in engineering or life sciences is required.

Qualifications

• 5+ years of validation experience in regulated manufacturing.
• Bachelor's degree in Engineering, Life Sciences, or related field.
• Experience with CQV projects for facility systems or processes.
• Knowledge of aseptic processing and QC laboratories.

Responsibilities

• Lead commissioning, qualification, and validation for facility systems and equipment.
• Develop, execute, and review IQ/OQ/PQ protocols and validation plans.
• Support validation across aseptic formulations, filling, packaging, and labs.
• Collaborate with engineering, QA, manufacturing, IT to meet timelines.
• Investigate deviations and ensure FDA/EU-GMP compliance.

Skills

CQV experience

GMP knowledge

Cross-functional collaboration

FDA guidance familiarity

Aseptic processing understanding

Education

Bachelor's degree in Engineering / Life Sciences / Computer Science

Tools

CQV documentation tools

Job description

Piper Companies seeks a Validation Engineer to support GMP-regulated operations at a Clayton, NC site. You will lead CQV activities for facility systems, equipment, and utilities in a fully onsite role.

The role requires 5+ years CQV experience, knowledge of aseptic processing, FDA guidance, and collaboration with engineering, quality, IT, and manufacturing to meet regulatory timelines and quality objectives. A Bachelor's in engineering or life sciences is required.