Senior Validation Engineer – GMP CQV Lead (Onsite, 24-Month)

Piper Companies; Clayton (NC); On-site; USD 140,000 - 165,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Sick leave

401K

Job summary

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing organization in Clayton, NC. This 24-month contract assignment focuses on manufacturing validation initiatives within aseptic fill-finish, packaging systems, and device assembly environments.

This onsite role requires driving multiple projects with limited oversight in a fast-paced GMP setting. The candidate should have extensive validation experience, IQ/OQ/PQ expertise, and strong

Qualifications

• 5-10 years of hands-on manufacturing validation experience in regulated pharmaceutical/biotech environments.
• Experience authoring and executing IQ, OQ, PQ, process validation, commissioning, and qualification docs for GMP systems.
• Ability to manage multiple projects with minimal supervision and drive results.
• Knowledge of FDA regulations, GMP, GAMP, Annex 15, and validation lifecycle methodologies.
• Experience supporting equipment upgrades, production line modifications, and electronic quality documentation.

Responsibilities

• Lead commissioning, qualification, and validation activities for manufacturing equipment, lines, and facility systems.
• Develop and execute lifecycle validation documents including strategies, risk assessments, protocols, and reports.
• Support multiple concurrent capital and operational projects across packaging, device assembly, sterile filling, utilities, and production infrastructure.
• Investigate validation deviations, assess engineering changes, and support change control while ensuring regulatory compliance.
• Coordinate with project managers, engineering, vendors, and operations to meet timelines.

Skills

Validation engineering

Regulatory compliance

GMP knowledge

Independent project management

Documentation & traceability

Job description

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing organization in Clayton, NC. This 24-month contract assignment focuses on manufacturing validation initiatives within aseptic fill-finish, packaging systems, and device assembly environments.

This onsite role requires driving multiple projects with limited oversight in a fast-paced GMP setting. The candidate should have extensive validation experience, IQ/OQ/PQ expertise, and strong