Onsite Pharma Validation Engineer | GMP & CSV Expert

Zachary Piper Solutions; Clayton (NC); On-site; USD 98,000 - 112,000; Full time

Job summary

Piper Companies is seeking a Validation Engineer to join a leading pharmaceutical manufacturing organization for a long-term onsite contract in Clayton, NC. The role focuses on diverse project work across manufacturing, facilities, laboratory, automation, and quality systems.

The engineer will ensure compliance with GMP, FDA regulations, GAMP 5, and Annex 15 while delivering robust validation activities and documentation. This onsite position supports a regulated environment.

Qualifications

• 5+ years of validation experience in pharmaceutical, biotech, or regulated manufacturing.
• Hands-on validation for equipment, aseptic processing, packaging, lab, utilities, or facilities.
• Knowledge of computerized systems validation; familiarity with SCADA, PLCs, PAS-X, LMES, Veeva, HP ALM/TIMS.
• Experience authoring/ executing qualification protocols, validation reports, risk assessments, and electronic validation docs.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or related technical field.

Responsibilities

• Develop, revise, and maintain validation lifecycle docs (plans, specs, risk assessments, traceability, reports).
• Author and execute IQ/OQ/PQ, design reviews, commissioning support, and process validation.
• Partner with PMs, engineering, quality, and vendors for upgrades and automation initiatives.
• Investigate deviations, assess impacts, document corrective actions, and support change control.
• Ensure validation deliverables meet GMP and FDA requirements; align with GAMP 5 and Annex 15.

Skills

Validation experience

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical discipline

Tools

SCADA

PLCs

PAS-X

LMES

Veeva

HP ALM/TIMS

Job description

Piper Companies is seeking a Validation Engineer to join a leading pharmaceutical manufacturing organization for a long-term onsite contract in Clayton, NC. The role focuses on diverse project work across manufacturing, facilities, laboratory, automation, and quality systems.

The engineer will ensure compliance with GMP, FDA regulations, GAMP 5, and Annex 15 while delivering robust validation activities and documentation. This onsite position supports a regulated environment.