Senior Validation Engineer: GMP Automation Lead (Onsite)

ZP Group; Clayton (NC); On-site; USD 102,000 - 116,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Job summary

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract in Clayton, NC. You will lead validation activities for automated manufacturing systems, equipment, and processes within a GMP environment.

Key duties include developing and executing IV, OV, and PV protocols, managing change controls, and authoring validation plans and quality records to sustain validated state.

Qualifications

• Bachelor's degree in Engineering, CS, or related technical discipline.
• 7+ years of validation experience in regulated manufacturing (pharma/biotech/medical devices).
• Strong knowledge of GMP, FDA 21 CFR Part 11, GAMP5, ICH, and CSV principles.
• Experience with automated manufacturing equipment validation and change control.
• Proven project leadership managing multiple initiatives and cross-functional teams.

Responsibilities

• Lead development, execution, analysis, and reporting of IV, OV, and PV protocols for manufacturing equipment and processes.
• Manage validation-related change controls and ensure compliance with regulatory and site quality standards.
• Author and maintain validation plans, project quality documentation, procedures, specs, and supporting records.
• Drive investigations for validation deviations, failures, and nonconformances using root cause analysis.
• Support FAT, SAT, commissioning, and startup activities while coordinating validation projects and cross-functional stakeholders.

Skills

Validation engineering

Regulatory compliance

Project leadership

GMP knowledge

Root cause analysis

Education

Bachelor's degree in Engineering/CS

Advanced degree preferred

Tools

Computerized system validation

Job description

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract in Clayton, NC. You will lead validation activities for automated manufacturing systems, equipment, and processes within a GMP environment.

Key duties include developing and executing IV, OV, and PV protocols, managing change controls, and authoring validation plans and quality records to sustain validated state.