Senior Validation Engineer - 176691

Piper Companies; Clayton (NC); On-site; USD 102,000 - 116,000; Full time

Benefits offered by this job

Comprehensive Benefits: Medical,Dental

Sick leave and 401K

Job summary

Piper Companies is seeking a Senior Validation Engineer for an onsite contract in Clayton, NC. The role leads validation activities across automated manufacturing systems in a GMP environment, supporting large-scale pharmaceutical projects, and coordinating cross-functional teams.

The position requires a strong foundation in validation, regulatory compliance, and project leadership, with experience in IV/OV/PV testing and change control processes.

Qualifications

• Knowledge of GMP requirements and regulatory expectations.
• Experience validating automated manufacturing equipment and systems.
• Proven ability to lead validation projects and cross-functional teams.

Responsibilities

• Lead IV, OV, and PV protocols for equipment and processes.
• Manage validation change controls and regulatory documentation.
• Author validation plans and quality records for validated state.
• Investigate validation deviations using root cause analysis.
• Coordinate FAT, SAT, commissioning, and startup activities.

Skills

GMP compliance

FDA regulations

CSV & validation principles

Project leadership

Root cause analysis

Education

Bachelor's degree in Engineering/Computer Science

Job description

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract position located in Clayton, NC. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes while supporting large-scale pharmaceutical production projects in a regulated GMP environment.

Responsibilities of the Senior Validation Engineer include:

• Lead the development, execution, analysis, and reporting of Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) protocols for manufacturing equipment and processes.
• Manage validation-related change controls, review protocol documentation, and ensure all activities meet regulatory and site quality standards.
• Author and maintain validation plans, project quality documentation, procedures, specifications, and supporting records required to sustain a validated state.
• Drive investigations associated with validation deviations, failures, and nonconformances using structured root cause analysis methodologies.
• Support FAT, SAT, commissioning, and startup activities while coordinating validation project schedules, contractors, and cross-functional stakeholders.

Qualifications for the Senior Validation Engineer include:

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline; advanced degree preferred.
• 7+ years of validation experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Strong knowledge of GMP requirements, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines, and computerized system validation principles.
• Demonstrated experience with automated manufacturing equipment validation, change management, and complex root cause investigations.
• Proven project leadership skills with the ability to manage multiple initiatives, technical documentation, timelines, and cross-functional teams.

Compensation for the Senior Validation Engineer:

Salary Range: $74-$84/hr (USD)

• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

Keywords: validation engineer, process validation, equipment validation, computerized systems validation, CSV, GMP, pharmaceutical manufacturing, biotechnology, FDA compliance, 21 CFR Part 11, GAMP5, change control, deviation investigation, CAPA, root cause analysis, commissioning, FAT, SAT, IQ, OQ, PQ, automation systems, quality assurance, validation protocols, technical writing, project management, manufacturing processes, regulatory compliance, SOP development, engineering validation, quality systems, process improvement, biotech manufacturing.

#LI-MB1 #LI-ONSITE