Senior Validation Engineer - GMP/CSV, Onsite

ZP Group; Clayton (NC); On-site; USD 203,444,000 - 232,098,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Sick leave

401K

Job summary

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

Responsibilities include leading IQ/OQ/PQ activities, risk assessments, change control, deviations, and ensuring compliance with GMP, FDA, and GAMP 5.

Qualifications

• 5+ years of validation experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Experience supporting manufacturing equipment, aseptic processing systems, packaging operations, laboratory environments, utilities, or facility infrastructure projects.
• Knowledge of computerized systems validation and platforms such as SCADA, PLCs, PAS-X, LMES, Veeva, HP ALM/TIMS, or similar systems.
• Experience authoring and executing qualification protocols, validation reports, risk assessments, and electronic validation documentation with minimal supervision.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or related technical discipline.

Responsibilities

• Develop, revise, and maintain validation lifecycle documentation including validation plans, specifications, risk assessments, traceability matrices, reports, and change control records.
• Author and execute qualification and validation activities such as IQ, OQ, PQ, design reviews, commissioning support, and process validation for manufacturing and facility-based projects.
• Partner with project managers, engineering teams, quality personnel, and vendors to support equipment upgrades, facility modifications, automation initiatives, and technology modernization efforts.
• Investigate deviations, assess validation impacts, document corrective actions, and support change management activities throughout project execution.
• Ensure all validation deliverables meet GMP requirements and align with FDA regulations, GAMP 5 principles, Annex 15 guidance, and internal quality procedures.

Skills

Validation experience

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

SCADA

PLC

PAS-X

LMES

Veeva

HP ALM/TIMS

Job description

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

Responsibilities include leading IQ/OQ/PQ activities, risk assessments, change control, deviations, and ensuring compliance with GMP, FDA, and GAMP 5.