Senior Validation Engineer

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 Senior Validation Engineer opportunity is a 24-month contract assignment running through November 2028 and is focused on manufacturing validation initiatives within aseptic fill-finish operations, packaging systems, and medical device assembly environments. This position requires full‑time onsite presence and is ideal for a validation professional who thrives in fast‑paced GMP manufacturing settings and can drive multiple projects with limited oversight.

Responsibilities

• Lead commissioning, qualification, and validation activities for manufacturing equipment, production lines, and facility systems supporting pharmaceutical operations.
• Develop and execute lifecycle validation documentation including validation strategies, risk assessments, protocols, traceability documentation, and final summary reports.
• Support multiple concurrent capital and operational projects involving packaging equipment, device assembly systems, sterile filling processes, utilities, facilities, and production infrastructure.
• Investigate validation‑related deviations, assess the impact of engineering changes, and support change control activities while ensuring regulatory compliance.
• Partner with project managers, engineering teams, vendors, and operations personnel to provide project updates, coordinate validation activities, and meet demanding implementation timelines.

Qualifications

• 5-10 years of hands‑on manufacturing validation experience within regulated pharmaceutical or biotechnology environments, with a strong preference for packaging, fill‑finish, or device assembly operations.
• Demonstrated expertise authoring and executing IQ, OQ, PQ, process validation, commissioning, and qualification documentation for GMP manufacturing systems.
• Proven ability to work independently, manage priorities across multiple projects, and deliver results with minimal supervision.
• Working knowledge of FDA regulations, GMP requirements, GAMP principles, Annex 15 guidance, and validation lifecycle methodologies.
• Experience supporting equipment upgrades, production line modifications, automated manufacturing systems, and electronic quality documentation platforms.

Compensation

• Salary Range: $140,000 - $165,000 annually
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

Application Details

• Location: Clayton, NC
• Work Schedule: 100% Onsite, 5 Days Per Week
• Employment Type: 24-Month Contract
• Contract Duration: Approximately December 2026 through November 2028
• Posting Date: 10.6.26

Keywords

Validation Engineering, GMP, Pharmaceutical Manufacturing, Commissioning, Qualification, CQV, IQ, OQ, PQ, Process Validation, Fill Finish, Aseptic Processing, Sterile Manufacturing, Packaging Equipment, Device Assembly, RABS, Manufacturing Validation, Risk Assessment, Traceability Matrix, Change Control, Deviation Investigation, Engineering Projects, Production Equipment, Process Controls, SCADA, PLC, MES, PAS-X, Validation Lifecycle, Facility Validation, Utility Systems, HVAC, Cold Storage, Warehouse Validation, FAT, SAT, GAMP 5, FDA Compliance, Annex 15, Veeva, Quality Systems, Capital Projects, Equipment Upgrades